Conmed
CONMED ELECTROSURGICAL ACCESSORY, Loop Excision Electrode, 20 mm x 10 mm
6manufacturers in China registered for this device type
6catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (3), Zhejiang (3). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Modern Medical Equipment Manufacturing Ltd. | Heng Li, Dongguan | Guangdong | Contract manufacturer | 26 |
| Zhejiang Shuyou Surgical Instrument Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 13 |
| Ningbo Shun YE Medical Company, Ltd. | Cixi Ningbo | Zhejiang | Contract manufacturer | 8 |
| Modern Medical Equipment Manufacturing (Qing Yuan) Ltd | Qing Yuan | Guangdong | Contract manufacturer | 26 |
| Shenzhen JPY ION-Tech. Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 20 |
| Zhejiang Jinhua Huatong Medical Appliance Co., Ltd. | Jinhua | Zhejiang | Manufacturer | 4 |
Record
| Listed by | ConMed Corporation, United States |
|---|---|
| FDA product code | HGI |
| Device type | Electrocautery, Gynecologic (And Accessories) |
| Device class | Class 2 |
| Regulation | 21 CFR 884.4120 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K913213 |
| Record published | 2016-09-24 |
| Record revised | 2024-08-20 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment humidity 5 to 70 % RH; Storage environment temperature 10 to 32 °C; Storage environment temperature 50 to 90 °F |
| Packaging | Box of 5, carton of 5 |
| Sizes | Outer diameter 5 mm |
| Distribution end date | 2022-06-09 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 60-5181-102 | 5 | In distribution | |
| 60-5180-104 | 5 | In distribution | |
| 60-5180-102 | Loop Excision Electrode | 5 | In distribution |
| 60-5181-103 | Outer Diameter 5 mm | 5 | In distribution |
| 60-5180-101 | Loop Excision Electrode | 5 | In distribution |
| 60-5181-101 | Ball Electrode | 5 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Bovie | Aspen Surgical Products, Inc. | 138 |
| DeRoyal | Deroyal Industries, Inc. | 27 |
| Electrocautery, Gynecologic (And Accessories) | C R I | 24 |
| Greenwald Surgical Company, Inc. | Grace Manufacturing Inc | 22 |
| Valleylab | Aspen Surgical Products, Inc. | 20 |
| Argent | Mckesson Medical-Surgical Inc. | 19 |
| Carrera Loop Electrodes | Gynex Corporation | 19 |
| Weck | Teleflex Medical LLC | 18 |
| Radius Loop ELectrodes | Gynex Corporation | 13 |
| Aesculap | Aesculap AG | 11 |
| Leep Radius Electrode | Coopersurgical, Inc. | 10 |
| Premier | Premier Dental Products Co. | 9 |
Showing 12 of 70. All products under Electrocautery, Gynecologic (And Accessories)
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.