The following data is part of a premarket notification filed by Boston Endo-surgical Technologies, Inc. with the FDA for Bipolar Forceps.
| Device ID | K131058 |
| 510k Number | K131058 |
| Device Name: | BIPOLAR FORCEPS |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | BOSTON ENDO-SURGICAL TECHNOLOGIES, INC. 1146 BARNUM AVENUE Bridgeport, CT 06610 |
| Contact | James Rogers |
| Correspondent | James Rogers BOSTON ENDO-SURGICAL TECHNOLOGIES, INC. 1146 BARNUM AVENUE Bridgeport, CT 06610 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-16 |
| Decision Date | 2013-10-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00853508002119 | K131058 | 000 |
| 00853508002096 | K131058 | 000 |
| 00853508002065 | K131058 | 000 |
| 00853508002058 | K131058 | 000 |
| 00853508002034 | K131058 | 000 |
| 00853508002546 | K131058 | 000 |