Barrx
Channel RFA Endoscopic Catheter,Esophageal TTS, 120 Applications
65manufacturers in China registered for this device type
32catalogue 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) | K120431 |
| Record published | 2016-09-24 |
| Record revised | 2025-06-24 (version 17) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Handling environment temperature 20 to 30 °C; Handling environment humidity 20 to 65 % RH; Handling environment atmospheric pressure from 79 KiloPascal; Special storage condition: Keep dry |
| Packaging | Pack_or_inner_pack of 10, case of 10, case of 5 |
| Sizes | Width 7.5 to 13 mm; length 10.75 to 40 mm; outer diameter 18 to 47.5 mm |
| Distribution end date | 2024-07-03 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 90-9200 | Width 13 mm | In distribution |
| 1190A-115A-01-R | In distribution | |
| 1190A-115A | In distribution | |
| 64082 | In distribution | |
| TTS-1100 | Width 7.5 mm | In distribution |
| TTS-2100 | Length 10.75 mm | In distribution |
| 90-9300 | Length 15 mm | In distribution |
| AR-1000 | Length 15 mm | In distribution |
| CP-002A | In distribution | |
| 64082-01 | In distribution | |
| CP-001A | Size,small,N/A; | In distribution |
| FLEXCC-020A | In distribution | |
| CP-001A | In distribution | |
| TTS-1500 | Width 7.5 mm | In distribution |
| 1190A-230A | Electric Pressure,220-240,V;Current,4A 50,Hertz; | In distribution |
| CP-002A | Size,medium,N/A; | In distribution |
| FLEXFS-010A | In distribution | |
| 1190A-230A | In distribution | |
| TTS-1100 | Length 15.7 mm | In distribution |
| 90-9300 | Length 15 mm | In distribution |
| 90-9500 | Length 20 mm | In distribution |
| 90-9200 | Length 40 mm | In distribution |
| 1190A-230A-01 | In distribution | |
| 90-9100 | Length 20 mm | In distribution |
| 90-9100 | Width 13 mm | In distribution |
| 32041-31 | Outer Diameter 31 mm | Withdrawn |
| 32041-25 | Outer Diameter 25 mm | Withdrawn |
| 3441C | Outer Diameter 47.5 mm | Withdrawn |
| 32041-18-01 | Greatest Diameter, 18MM; | Withdrawn |
| 3441B | Outer Diameter 34 mm | Withdrawn |
| 32041-28 | Outer Diameter 28 mm | Withdrawn |
| 32041-22 | Outer Diameter 22 mm | 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
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Covidien | 510(k) number | 2012-08-03 | Class II | Software design | Potential failure of HALO Energy Generator to enter “stand by” mode when initially powered on; and therefore can not be used for patient care. | 617 generators | 2013-09-30 |
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.