Carrera Loop Electrode
2 catalogue numbers from OCMR-1508, listed by Gynex Corporation, United States, under Electrocautery, Gynecologic (And Accessories). 6 manufacturers in China are registered for this product code.
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 | Gynex Corporation, United States |
|---|---|
| FDA product code | HGI |
| Device type | Electrocautery, Gynecologic (And Accessories) |
| Device class | Class 2 |
| Regulation | 21 CFR 884.4120 |
| Establishment | Repacker / relabeller |
| 510(k) | K982739 |
| Record published | 2017-01-19 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| OCMR-1508 | 5 | In distribution | |
| CMB-2-3-2 | 5 | In distribution |
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)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K982739 | 1999-03-12 |
Recalls
1 of these is Class III. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2012-09-06 | Class III | Nonconforming Material/Component | The wrong electrical connector pin was attached to the cord during assembly by the manufacturer. this electrical connector is too big to fit into the port on the foot activated generator. this makes the device unusable. | 19 boxes (containing 12 electorde hand pieces each) | 2012-10-22 |
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.