The following data is part of a premarket notification filed by General Surgical Innovations with the FDA for Gsi Cannula Reducer Accessory.
| Device ID | K943671 |
| 510k Number | K943671 |
| Device Name: | GSI CANNULA REDUCER ACCESSORY |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | GENERAL SURGICAL INNOVATIONS 3280 ALPINE RD. Portola Valley, CA 94028 |
| Contact | Thomas J Fogarty |
| Correspondent | Thomas J Fogarty GENERAL SURGICAL INNOVATIONS 3280 ALPINE RD. Portola Valley, CA 94028 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-26 |
| Decision Date | 1994-08-09 |