Bovie
RESISTICK™II COATED ANGLED 45° ELECTRODE 2.75'' (6.98CM) Resistick™ II Coated Angled Blade 45° Electrode 2.75"
65manufacturers in China registered for this device type
390catalogue 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 | Aspen Surgical Products, Inc., United States |
|---|---|
| FDA product code | GEI |
| Device type | Electrosurgical, Cutting & Coagulation & Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4400 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K936304 |
| Record published | 2024-08-28 |
| Record revised | 2025-12-30 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment temperature 10 to 30 °C; Handling environment humidity 10 to 75 % RH |
| Packaging | Box of 10, pack of 10, box of 5, pack of 12, pack of 50, box of 50 |
| Sizes | Length 2 to 8 in; width 0.5 to 4 mm; outer diameter 3 to 5 mm; shaft length 2 to 5 in; angle 45 ° |
| Distribution end date | 2025-07-21 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| ESP1 | In distribution | ||
| ESP1TN | In distribution | ||
| ES56T | Length 4 in | In distribution | |
| A802EU | In distribution | ||
| ES02R | In distribution | ||
| A940-P | In distribution | ||
| A827BP | In distribution | ||
| A835 | In distribution | ||
| H111 | In distribution | ||
| A1250S | In distribution | ||
| ESP6TN | In distribution | ||
| A844 | Length 3.5 in | In distribution | |
| SCF08 | In distribution | ||
| ES40T | Length 6 in | In distribution | |
| AR02 | In distribution | ||
| A830 | In distribution | ||
| ES43R | In distribution | ||
| ES06T | In distribution | ||
| H101 | In distribution | ||
| A3250-LOANER | In distribution | ||
| ES22R | In distribution | ||
| BA3350NA | In distribution | ||
| A833 | In distribution | ||
| GS100-DEMO | In distribution | ||
| ESPH | In distribution | ||
| ESP1T | In distribution | ||
| ESP7HS | In distribution | ||
| IDS-210 | In distribution | ||
| IDS-310T | In distribution | ||
| H109 | Shaft Length 5 in | In distribution | |
| A901 | In distribution | ||
| ESP7HS | In distribution | ||
| H112 | Shaft Length 5 in | In distribution | |
| A1250U-V-DEMO | In distribution | ||
| ESRS | In distribution | ||
| ESP1 | In distribution | ||
| ESP7HN | In distribution | ||
| A811 | In distribution | ||
| ESP7N | In distribution | ||
| ES24R | In distribution | ||
| LJ07 | In distribution | ||
| ESP1HN | In distribution | ||
| A952 | In distribution | ||
| A842 | In distribution | ||
| DEL2 | In distribution | ||
| A1254C | In distribution | ||
| A940-LOANER | In distribution | ||
| A840 | Length 4 in | In distribution | |
| BA2455NA | In distribution | ||
| A1250U | In distribution | ||
| IDS-310-DEMO | In distribution | ||
| LH01 | In distribution | ||
| IDS-310 | In distribution | ||
| DEL0 | In distribution | ||
| A840 | In distribution | ||
| H101 | In distribution | ||
| ESP1N | In distribution | ||
| ES20T | Length 2 in | In distribution | |
| ES42R | In distribution | ||
| A1203 | In distribution | ||
| LS05 | Width 4 mm | In distribution | |
| ESP6 | In distribution | ||
| BVX-LH08T-NS | 25 | In distribution | |
| ESPR2 | In distribution | ||
| A1250U-V | In distribution | ||
| A832M | In distribution | ||
| A831 | In distribution | ||
| A902 | In distribution | ||
| ESP1H | In distribution | ||
| IDS-310 | In distribution | ||
| ESP7H | In distribution | ||
| A825 | Length 4.75 in | In distribution | |
| SCH08 | In distribution | ||
| LJ07 | Width 4 mm | In distribution | |
| A1204 | In distribution | ||
| ES03T | Length 6 in | In distribution | |
| SCH12 | In distribution | ||
| ESREC | In distribution | ||
| ES26R | In distribution | ||
| A905A | In distribution | ||
| A843 | In distribution | ||
| ES03T | In distribution | ||
| ESP6HN | In distribution | ||
| ESP6N | In distribution | ||
| A823 | Length 7 in | In distribution | |
| IDS-400 | In distribution | ||
| A1252C | In distribution | ||
| BVX-LJ07T-NS | 25 | In distribution | |
| A1204C | In distribution | ||
| GP300-LOANER | In distribution | ||
| ESPH | In distribution | ||
| HISL | In distribution | ||
| ES60R | In distribution | ||
| A902 | In distribution | ||
| ES06R | In distribution | ||
| ES15R | In distribution | ||
| IDS-300-DEMO | In distribution | ||
| A1255A | In distribution | ||
| BV-1254LM | In distribution | ||
| A821 | Length 8 in | In distribution | |
| DEL2 | In distribution | ||
| H106 | In distribution | ||
| LH01 | Width 4 mm | In distribution | |
| ES55T | In distribution | ||
| ESP1HN | In distribution | ||
| ESSP | In distribution | ||
| ES01T | Length 2.75 in | In distribution | |
| A844 | In distribution | ||
| BVX-LS05 | In distribution | ||
| ES18R | In distribution | ||
| ES02T | Length 2.75 in | In distribution | |
| ESP6H | In distribution | ||
| ESP1TH | In distribution | ||
| AA25 | In distribution | ||
| Derm 102 | In distribution | ||
| A841 | In distribution | ||
| ES57T | Length 4 in | In distribution | |
| ES37T | Length 2.75 in | In distribution | |
| IDS-310-LOANER | In distribution | ||
| BVX-LJ07-NS | 25 | In distribution | |
| LC04 | In distribution | ||
| ES46R | In distribution | ||
| ESP6N | In distribution | ||
| A832 | In distribution | ||
| GP300-REFURBISHED | In distribution | ||
| H121 | In distribution | ||
| BA3350A | In distribution | ||
| BV-1253BGI | In distribution | ||
| BVX-LC04T-NS | 25 | In distribution | |
| ES03R | In distribution | ||
| A940-DEMO | In distribution | ||
| LN03 | Width 4 mm | In distribution | |
| H105 | In distribution | ||
| ESP7 | In distribution | ||
| AA27 | In distribution | ||
| ES47R | In distribution | ||
| ESP7H | In distribution | ||
| BVX-LN03T-NS | 25 | In distribution | |
| AR03 | In distribution | ||
| ES53R | In distribution | ||
| A826 | Length 4.5 in | In distribution | |
| ESP1N | In distribution | ||
| ES31R | In distribution | ||
| H110 | In distribution | ||
| ES58T | In distribution | ||
| A901 | In distribution | ||
| ESRSC | In distribution | ||
| ES21T | Length 2 in | In distribution | |
| ES14R | In distribution | ||
| ES44R | In distribution | ||
| A822 | In distribution | ||
| HIT1 | In distribution | ||
| ES38T | Length 2.75 in | In distribution | |
| AA09 | In distribution | ||
| ESRS | In distribution | ||
| ES18 | Angle 45 ° | In distribution | |
| BVX-LS05-NS | 25 | In distribution | |
| A823 | In distribution | ||
| ES04R | In distribution | ||
| H104 | In distribution | ||
| ES54T | Length 4 in | In distribution | |
| BVX-LB02T-NS | 25 | In distribution | |
| ES02R | In distribution | ||
| LN03 | In distribution | ||
| ES41R | In distribution | ||
| A1452C | In distribution | ||
| ES01T | In distribution | ||
| IDS-210-DEMO | In distribution | ||
| A940-TRAB | In distribution | ||
| A827F | In distribution | ||
| ES49R | In distribution | ||
| ES18R | Angle 45 ° | In distribution | |
| DEL0 | In distribution | ||
| BA1860NA | In distribution | ||
| ES01 | In distribution | ||
| A2350 | In distribution | ||
| BVX-LL06-NS | 25 | In distribution | |
| AR00-NS | 50 | In distribution | |
| H110 | In distribution | ||
| H101-ADH | In distribution | ||
| AA27 | In distribution | ||
| A1204 | In distribution | ||
| H106 | Shaft Length 2 in | In distribution | |
| A801EU | In distribution | ||
| SCF08 | In distribution | ||
| A826 | In distribution | ||
| BV-1254B | In distribution | ||
| A2250-LOANER | In distribution | ||
| SCF10 | In distribution | ||
| BVX-LH01-NS | 25 | In distribution | |
| BV-1253B | In distribution | ||
| A827V | In distribution | ||
| GI120-LOANER | In distribution | ||
| ES08R | In distribution | ||
| SCF12 | In distribution | ||
| H112 | In distribution | ||
| GP300 | In distribution | ||
| ESP6HS | In distribution | ||
| BVX-LH01 | In distribution | ||
| LS05 | In distribution | ||
| A841 | Length 3.5 in | In distribution | |
| BVX-LS05T-NS | 25 | In distribution | |
| AR00 | In distribution | ||
| AA29 | In distribution | ||
| ES07T | Length 5 in | In distribution | |
| A1202C | In distribution | ||
| A1250U-V-LOANER | In distribution | ||
| AR01 | In distribution | ||
| ES03R | In distribution | ||
| IDS-300 | In distribution | ||
| LH08 | In distribution | ||
| IDS-300-REBURBISHED | In distribution | ||
| H100 | In distribution | ||
| A1204C | In distribution | ||
| H103 | In distribution | ||
| BVX-LB02 | In distribution | ||
| SCH08 | In distribution | ||
| ES55R | In distribution | ||
| ES45R | In distribution | ||
| A1250U-VP | In distribution | ||
| A833 | In distribution | ||
| ES01R | In distribution | ||
| ES21T | In distribution | ||
| ES01R | In distribution | ||
| A942 | In distribution | ||
| ES54T | In distribution | ||
| ES10R | In distribution | ||
| BVX-LH01T-NS | 25 | In distribution | |
| A1204P | In distribution | ||
| ES58R | In distribution | ||
| A1252C | In distribution | ||
| ES11R | In distribution | ||
| SCH12 | In distribution | ||
| LB02 | In distribution | ||
| ESP7N | In distribution | ||
| AA17 | Shaft Length 2 in | In distribution | |
| GS100-LOANER | In distribution | ||
| BV-1254B | In distribution | ||
| A825 | In distribution | ||
| A1203W | In distribution | ||
| H105 | Shaft Length 2 in | In distribution | |
| ES12R | In distribution | ||
| H104 | In distribution | ||
| ES59T | Length 2.5 in | In distribution | |
| BVX-LC04 | In distribution | ||
| A1254C | In distribution | ||
| A834T | In distribution | ||
| ESP1T | In distribution | ||
| A843 | Length 4 in | In distribution | |
| BVX-LL06 | In distribution |
Showing 250 of 300 catalogue numbers.
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 |
|---|---|
| K030339 | 2003-03-07 |
Recalls Naming This Product
4 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 |
|---|---|---|---|---|---|---|---|
| ConMed Corporation | 510(k) number | 2022-11-18 | Class II | Process control | Suction ports may potentially be occluded on the affected devices. If this occurs, the affected devices will not be able to perform the suction function during use, which could cause a delay in procedure and could require another device to | 23,700 US; 5,225 OUS | 2026-04-13 |
| Olsen Medical | 510(k) number | 2018-05-11 | Class II | Package design/selection | Products may encroach into the sterile pouch seal thereby increasing the risk of the seal being compromised. | 665,350 devices | 2019-04-15 |
| PSC Industries Inc | 510(k) number | 2012-06-05 | Class II | Labeling mix-ups | The carton label for this device has the manufacturer symbol where the expiration date symbol should be. Firm officials met with FDA on 5/17/2012. At which time, they reported various labeling errors for their Button Switch Pen Electrode E | 50 units | 2014-01-17 |
| PSC Industries Inc | 510(k) number | 2012-06-05 | Class II | Labeling mix-ups | The Tyvek pouch label for this device states: ‘with holster’; however, this product does not come with a holster. Firm officials met with FDA on 5/17/2012. At which time, they reported various labeling errors with their Button Switch Pen | 725 units (125=Lot #023392 & 600 units Lot #022438) | 2014-01-17 |
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.