The following data is part of a premarket notification filed by Medos International Sarl with the FDA for Codman Versatru Standard Disposable Non-stick Bipolar Forceps, Codman Versatru Slim Disposable Non-stick Bipolar Forceps.
| Device ID | K162469 |
| 510k Number | K162469 |
| Device Name: | CODMAN VersaTru Standard Disposable Non-Stick Bipolar Forceps, CODMAN VersaTru Slim Disposable Non-Stick Bipolar Forceps |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Medos International SARL Chemin-Blanc 38 Le Locle, CH 2400 |
| Contact | Jennifer Siu |
| Correspondent | Jennifer Siu Medos International SARL Chemin-Blanc 38 Le Locle, CH 2400 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-02 |
| Decision Date | 2016-10-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10886704079996 | K162469 | 000 |
| 10886704079927 | K162469 | 000 |
| 10381780521471 | K162469 | 000 |
| 10886704080008 | K162469 | 000 |
| 10886704079941 | K162469 | 000 |
| 10886704080015 | K162469 | 000 |
| 10886704079958 | K162469 | 000 |
| 10886704080022 | K162469 | 000 |
| 10381780521594 | K162469 | 000 |
| 10381780521617 | K162469 | 000 |
| 10886704079972 | K162469 | 000 |
| 10886704080046 | K162469 | 000 |
| 10381780521679 | K162469 | 000 |
| 10886704080053 | K162469 | 000 |
| 10886704079910 | K162469 | 000 |