Valleylab
Telescoping Smoke Evacuation Rocker Switch Pencil Edge (TM) Blade Electrode, Non-Sterile Bulk;Caution: For manufacturing, processing, or repacking.
65manufacturers in China registered for this device type
198catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Guangdong (24), Zhejiang (13), Shanghai (10). 23 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Hangzhou Kangji Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Modern Medical Equipment Manufacturing Ltd. | Heng Li, Dongguan | Guangdong | Contract manufacturer | 26 |
| Amphenol Alden Products Company | Shenzhen | Guangdong | Contract manufacturer | 24 |
| Hangzhou Endo Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 19 |
| Hong Qiangxing (Shen Zhen) Electronics Limited | Shenzhen | Guangdong | Contract manufacturer | 19 |
| Shenzhen MED-Link Electronics Tech Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 18 |
| Sanbor Medical Xiamen, Inc. | Xiamen | Fujian | Contract manufacturer | 16 |
| ATL Technology DG,Ltd. | Dongguan | Guangdong | Contract manufacturer | 14 |
| Jiangyin Sinbon Electronics Co Ltd | Jiangyin | Jiangsu | Contract manufacturer | 13 |
| Guangzhou Huada Biotechnology Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 9 |
Showing 12 of 65. All 65 manufacturers in China registered for Electrosurgical, Cutting & Coagulation & Accessories
Record
| Listed by | Covidien LP, United States |
|---|---|
| FDA product code | GEI |
| Device type | Electrosurgical, Cutting & Coagulation & Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4400 |
| 510(k) | K946177 |
| Record published | 2016-09-24 |
| Record revised | 2025-06-24 (version 15) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Radiation Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment humidity 0 to 75 % RH; Storage environment temperature -29 to 149 °F |
| Packaging | Pack_or_inner_pack of 10, case of 25, case of 50, case of 10, case of 15, case of 4 |
| Sizes | Length 2 to 45 cm; length 9 to 15 ft; length 0.065 to 15 in; catheter gauge 8 to 12 Fr; length 3 to 4.6 m; length 3.2 to 9.5 mm |
| Distribution end date | 2026-07-15 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| E6019 | In distribution | ||
| E2100E | Length 15 ft | In distribution | |
| E2783-28 | Length 28 cm | In distribution | |
| E0020V | Length 15 ft | In distribution | |
| E1551-6NSB | Length 6.5 in | 100 | In distribution |
| CVPLP2000 | In distribution | ||
| E2100 | Length 15 ft | In distribution | |
| E1652 | angle,45 degrees, 3 mm from tip; | In distribution | |
| E3786-28 | Length 28 cm | In distribution | |
| E0560 | Length 15 ft | In distribution | |
| E1020 | Length 2.75 in | In distribution | |
| CVPLP2000 | In distribution | ||
| Force Argon II-8 | In distribution | ||
| E2401 | In distribution | ||
| E10520 | Length 10 ft | In distribution | |
| SEP6000 | Length 3 m | In distribution | |
| E3305 | Length 6 in | In distribution | |
| E0502-1 | In distribution | ||
| E1650 | Length 2 cm | In distribution | |
| E7510-25 | Length 9 ft | In distribution | |
| E4059-CT | tip,0.5,Millimeter; | In distribution | |
| E250510FRNSB | Length 6 in | 50 | In distribution |
| VLCM | In distribution | ||
| E2515HS | Length 10 ft | In distribution | |
| E0021S | Length 15 ft | In distribution | |
| E3781R-28ASP | Length 28 cm | In distribution | |
| E3782-28 | Length 28 cm | In distribution | |
| E3770-36 | Length 36 cm | In distribution | |
| E7508 | Weight, >30, Lbs; | In distribution | |
| E1552-6 | Length 6.5 in | In distribution | |
| E2750NSB | 10 | In distribution | |
| E3783-28 | Length 28 cm | In distribution | |
| E7509 | In distribution | ||
| E2608-6 | Length 6 in | In distribution | |
| E4073-CT | Length 22.2 cm | In distribution | |
| E4051-CT | tip, 1.5,Millimeter; | In distribution | |
| E4058-CT | Length 19.1 cm | In distribution | |
| E7512 | Length 9 ft | In distribution | |
| GR200A-20 | In distribution | ||
| E1654B | Length 9 cm | In distribution | |
| E3782R-28ASP | Length 28 cm | In distribution | |
| E2608-6 | Catheter Gauge 8 Fr | In distribution | |
| E2515NSB | Length 10 ft | 50 | In distribution |
| E4062-CT | Length 8.9 cm | In distribution | |
| E0017 | In distribution | ||
| E2516H | Length 10 ft | In distribution | |
| E2515HDB | Length 15 ft | In distribution | |
| E3773-36 | Length 36 cm | In distribution | |
| E2515HDANSB | Length 10 ft | 50 | In distribution |
| E3810 | Length 10 ft | In distribution | |
| E2515 | Length 10 ft | In distribution | |
| E3783R-36ASP | Length 36 cm | In distribution | |
| E2400NSB | 100 | In distribution | |
| E2516NSB | Length 10 ft | 50 | In distribution |
| E2516GNSB | Length 10 ft | 2,400 | In distribution |
| E2515HGNSB | Length 10 ft | 1,800 | In distribution |
| VL2610E | Length 15 in | In distribution | |
| E3784R-28ASP | Length 28 cm | In distribution | |
| E1000 | Length 3.2 mm | In distribution | |
| E1551G | Length 2.4 in | In distribution | |
| E3771-45 | Length 45 cm | In distribution | |
| E3781-28 | Length 28 cm | In distribution | |
| E7507 | Length 9 ft | In distribution | |
| E3305 | Length 6 in | In distribution | |
| E4055-CT | Length 10.2 cm | In distribution | |
| E0512-NSB | Length 12 ft | 50 | In distribution |
| E2781-28 | Length 28 cm | In distribution | |
| E3530-3 | Length 3 in | In distribution | |
| E2515HNSB | Length 10 ft | 50 | In distribution |
| E2515HSNSB | Length 10 ft | 50 | In distribution |
| E1003 | Length 2.6 in | In distribution | |
| E3310 | Catheter Gauge 10 Fr | In distribution | |
| E2581-28 | Length 28 cm | In distribution | |
| SEP6015NSB | Length 4.6 m | In distribution | |
| E1551-6 | Length 6.5 in | In distribution | |
| E7510-25DB | Length 15 ft | In distribution | |
| E0560E | Length 15 ft | In distribution | |
| E0022W | Length 15 ft | In distribution | |
| E2750 | In distribution | ||
| E0005-3C | Length 4 mm | In distribution | |
| FORCEARGONII20ZD | In distribution | ||
| E3772-36 | Length 36 cm | In distribution | |
| E3520H | In distribution | ||
| E7509B | Weight,Greater than 30,lbs; | 50 | In distribution |
| E250510FRNSB | Length 6 in | 50 | In distribution |
| E1504 | Length 34.3 cm | In distribution | |
| E0507B | In distribution | ||
| E0510 | Length 10 ft | In distribution | |
| E3504 | Length 10 ft | In distribution | |
| E3771-36 | Length 36 cm | In distribution | |
| E2516HGNSB | Length 10 ft | 1,800 | In distribution |
| E3504NSB | Length 10 ft | 120 | In distribution |
| E2515HDA | Length 10 ft | In distribution | |
| VLFT10FXGEN | In distribution | ||
| E3774-36 | Length 36 cm | In distribution | |
| E3773-45 | Length 45 cm | In distribution | |
| E2505-10FR | Catheter Gauge 10 Fr | In distribution | |
| E0512 | Length 12 ft | In distribution | |
| SEP6000NSB | Length 3 m | In distribution | |
| E2400 | In distribution | ||
| E3774-45 | Length 45 cm | In distribution | |
| E4053-CT | tip, 1.5,Millimeter; | In distribution | |
| E2515GNSB | Length 10 ft | 2,400 | In distribution |
| E3504H | Length 10 ft | In distribution | |
| E4057-CT | Length 19.1 cm | In distribution | |
| E2515HDBNSB | Length 15 ft | 50 | In distribution |
| E2516 | Length 10 ft | In distribution | |
| E1552 | Length 2.8 in | In distribution | |
| E0510NSB | Length 10 ft | 50 | In distribution |
| E2516HNSB | Length 10 ft | 50 | In distribution |
| E1550 | Length 5 mm | In distribution | |
| E4060-CT | Length 14.0 cm | In distribution | |
| SEP6015 | Length 4.6 m | In distribution | |
| E4052-CT | Length 15.2 cm | In distribution | |
| E3783R-28ASP | Length 28 cm | In distribution | |
| E2515H | Length 10 ft | In distribution | |
| E3815 | Length 15 ft | In distribution | |
| E1551X | Length 2.4 in | In distribution | |
| E2530-3 | Length 3 in | In distribution | |
| VL2610DB | Length 15 in | In distribution | |
| E4054-CT | tip,2.0,Millimeter; | In distribution | |
| Force Argon II-20 | In distribution | ||
| E3780-28 | Length 28 cm | In distribution | |
| E1502 | Length 13 cm | In distribution | |
| E3581-28 | Length 28 cm | In distribution | |
| E3580-28 | Length 28 cm | In distribution | |
| GR200A | In distribution | ||
| E3810NSB | Length 10 ft | 30 | In distribution |
| E7507DB | Length 15 ft | In distribution | |
| VL2610 | Length 10 in | In distribution | |
| E1651 | Length 3 cm | In distribution | |
| E3310 | Length 6 in | In distribution | |
| E2516HDA | Length 10 ft | In distribution | |
| E2786-28 | Length 28 cm | In distribution | |
| E3250H | In distribution | ||
| E1653 | angle,45 degrees, 1 cm from tip; | In distribution | |
| E2782R-28ASP | Length 28 cm | Withdrawn | |
| E2774-36 | Length 36 cm | Withdrawn | |
| E2773-36 | Length 36 cm | Withdrawn | |
| E10503 | Length 10 ft | Withdrawn | |
| E2784-28 | Length 28 cm | Withdrawn | |
| VL2600DB | Length 15 ft | 50 | Withdrawn |
| SEP5015 | Length 4.6 m | Withdrawn | |
| E2999 | Length 10 ft | Withdrawn | |
| SEA50595 | Length 10.16 cm | Withdrawn | |
| E2782-28 | Length 28 cm | Withdrawn | |
| E1512 | Withdrawn | ||
| VL2600 | Length 10 ft | 50 | Withdrawn |
| E1510 | Withdrawn | ||
| E2512H | Withdrawn | ||
| E2504H | Length 10 ft | Withdrawn | |
| E2784R-28ASP | Length 28 cm | Withdrawn | |
| E2580-28 | Length 28 cm | Withdrawn | |
| E2770-36 | Length 36 cm | Withdrawn | |
| E2583-28 | Length 28 cm | Withdrawn | |
| E2771-36 | Length 36 cm | Withdrawn | |
| E3530-28 | Length 28 cm | Withdrawn | |
| E2520H | Withdrawn | ||
| SEP5015NSB | Length 4.6 m | 30 | Withdrawn |
| E1511 | Withdrawn | ||
| E2516HS | Length 10 ft | Withdrawn | |
| E1002 | Length 5.6 mm | Withdrawn | |
| E2582-28 | Length 28 cm | Withdrawn | |
| E2003 | Length 10 ft | Withdrawn | |
| E2783R-28ASP | Length 28 cm | Withdrawn | |
| E7506 | Length 9 ft | Withdrawn | |
| E3305NSB | Catheter Gauge 12 Fr | 50 | Withdrawn |
| E2511H | angle,45,degrees; | Withdrawn | |
| E3250HNSB | 50 | Withdrawn | |
| E2781R-28ASP | Length 28 cm | Withdrawn | |
| E2783R-36ASP | Length 36 cm | Withdrawn | |
| VL2600E | Length 10 ft | Withdrawn | |
| VL2600NSB | Length 10 ft | 50 | Withdrawn |
| E0504-2 | Withdrawn | ||
| SEP5000NSB | Length 3 m | 30 | Withdrawn |
| E2530-28 | Length 28 cm | Withdrawn | |
| SEA54506 | Length 10.16 cm | Withdrawn | |
| E2532 | Length.065 in | Withdrawn | |
| E0503 | Length 10 ft | Withdrawn | |
| E2772-36 | Length 36 cm | Withdrawn | |
| E2780-28 | Length 28 cm | Withdrawn | |
| E2504 | Length 10 ft | Withdrawn | |
| E2532 | Length.065 in | Withdrawn | |
| SEP5000 | Length 3 m | Withdrawn | |
| E0509NSB | Length 12 ft | 50 | Withdrawn |
| E0018 | Length 12 ft | Withdrawn | |
| E3583-28 | Length 28 cm | Withdrawn | |
| GT100 | Withdrawn | ||
| E2771-45 | Length 45 cm | Withdrawn | |
| E0600 | Withdrawn | ||
| E0509 | Length 12 ft | Withdrawn | |
| E2510H | angle,90,degrees; | Withdrawn | |
| E2530-6 | Length 6 in | Withdrawn | |
| E3310NSB | Length 6 in | 50 | Withdrawn |
| E3530-6 | Length 6 in | Withdrawn | |
| E0520 | Length 10 ft | Withdrawn | |
| E1005 | Length 9.5 mm | Withdrawn | |
| E2773-45 | Length 45 cm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Surgical Direct | Surgical Direct, Inc. | 5,729 |
| Speedlock | National Advanced Endoscopy Devices, Inc. | 5,212 |
| Stingray Surgical Products | Stingray Surgical Products L.L.C. | 4,647 |
| Kirwan | Kirwan Surgical Products, LLC. | 1,901 |
| Millennium | Avalign Technologies, Inc. | 1,779 |
| DANmed | Dannoritzer Medizintechnik GmbH & Co. KG | 1,590 |
| Elmed | Elmed, Inc. | 1,519 |
| Symmetry Olsen | Aspen Surgical Products, Inc. | 1,219 |
| Guenter Bissinger Medizintechnik GmbH | Günter Bissinger Medizintechnik GmbH | 1,117 |
| Ambler Surgical | Ambler Surgical, LLC | 756 |
| V. Mueller | Steris Corporation | 661 |
| Aesculap | Aesculap AG | 544 |
Showing 12 of 2,922. All products under Electrosurgical, Cutting & Coagulation & Accessories
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K091223 | 2009-09-11 |
Recalls Naming This Product
26 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Covidien | 510(k) number | 2017-01-26 | Class II | Device Design | Customer reports of the device handset continuing to operate after release of the activation button. | 24,703 Units | 2018-08-08 |
| Covidien | 510(k) number | 2016-07-08 | Class II | Process control | Potential for compromise of the package resulting in a breach of the sterile barrier | 13420 | 2018-08-08 |
| Covidien | 510(k) number | 2016-07-08 | Class II | Process control | Potential for compromise of the package resulting in a breach of the sterile barrier | 19200 | 2018-08-08 |
| Covidien | 510(k) number | 2016-07-08 | Class II | Process control | Potential for compromise of the package resulting in a breach of the sterile barrier | 19200 | 2018-08-08 |
| Covidien | 510(k) number | 2016-07-08 | Class II | Process control | Potential for compromise of the package resulting in a breach of the sterile barrier | 6769 | 2018-08-08 |
| Covidien | 510(k) number | 2016-07-08 | Class II | Process control | Potential for compromise of the package resulting in a breach of the sterile barrier | 3530 | 2018-08-08 |
| Covidien | 510(k) number | 2016-07-08 | Class II | Process control | Potential for compromise of the package resulting in a breach of the sterile barrier | 210 | 2018-08-08 |
| Covidien | 510(k) number | 2016-07-08 | Class II | Process control | Potential for compromise of the package resulting in a breach of the sterile barrier | 2920 | 2018-08-08 |
| Covidien | 510(k) number | 2016-07-08 | Class II | Process control | Potential for compromise of the package resulting in a breach of the sterile barrier | 13516 | 2018-08-08 |
| Covidien | 510(k) number | 2016-07-08 | Class II | Process control | Potential for compromise of the package resulting in a breach of the sterile barrier | 161940 | 2018-08-08 |
| Covidien | 510(k) number | 2016-07-08 | Class II | Process control | Potential for compromise of the package resulting in a breach of the sterile barrier | 6381 | 2018-08-08 |
| Covidien | 510(k) number | 2016-07-08 | Class II | Process control | Potential for compromise of the package resulting in a breach of the sterile barrier | 85630 | 2018-08-08 |
| Covidien | 510(k) number | 2016-07-08 | Class II | Process control | Potential for compromise of the package resulting in a breach of the sterile barrier | 349629 | 2018-08-08 |
| Covidien | 510(k) number | 2016-07-08 | Class II | Process control | Potential for compromise of the package resulting in a breach of the sterile barrier | 24870 | 2018-08-08 |
| Covidien | 510(k) number | 2016-07-08 | Class II | Process control | Potential for compromise of the package resulting in a breach of the sterile barrier | 119770 | 2018-08-08 |
| Covidien | 510(k) number | 2016-07-08 | Class II | Process control | Potential for compromise of the package resulting in a breach of the sterile barrier | 6720 | 2018-08-08 |
| Covidien | 510(k) number | 2016-07-08 | Class II | Process control | Potential for compromise of the package resulting in a breach of the sterile barrier | 2018-08-08 | |
| Covidien | 510(k) number | 2016-07-08 | Class II | Process control | Potential for compromise of the package resulting in a breach of the sterile barrier | 2018-08-08 | |
| Covidien | 510(k) number | 2016-07-08 | Class II | Process control | Potential for compromise of the package resulting in a breach of the sterile barrier | 2018-08-08 | |
| Covidien | 510(k) number | 2016-07-08 | Class II | Process control | Potential for compromise of the package resulting in a breach of the sterile barrier | 1440 | 2018-08-08 |
| Covidien | 510(k) number | 2016-07-08 | Class II | Process control | Potential for compromise of the package resulting in a breach of the sterile barrier | 42900 | 2018-08-08 |
| Covidien | 510(k) number | 2016-07-08 | Class II | Process control | Potential for compromise of the package resulting in a breach of the sterile barrier | 63320 | 2018-08-08 |
| Covidien | 510(k) number | 2016-07-08 | Class II | Process control | Potential for compromise of the package resulting in a breach of the sterile barrier | 50055 | 2018-08-08 |
| Covidien | 510(k) number | 2016-07-08 | Class II | Process control | Potential for compromise of the package resulting in a breach of the sterile barrier | 332 | 2018-08-08 |
| Covidien | 510(k) number | 2016-07-08 | Class II | Process control | Potential for compromise of the package resulting in a breach of the sterile barrier | 3470 | 2018-08-08 |
| Covidien | 510(k) number | 2016-07-08 | Class II | Process control | Potential for compromise of the package resulting in a breach of the sterile barrier | 2018-08-08 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.