The following data is part of a premarket notification filed by Unisurge, Inc. with the FDA for Unitrocar(tm) Reusable Surg Trocar/resuse Kit.
| Device ID | K926341 |
| 510k Number | K926341 |
| Device Name: | UNITROCAR(TM) REUSABLE SURG TROCAR/RESUSE KIT |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | UNISURGE, INC. 10231 BUBB RD. Cupertino, CA 95014 |
| Contact | Donald V Johnson |
| Correspondent | Donald V Johnson UNISURGE, INC. 10231 BUBB RD. Cupertino, CA 95014 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-12-17 |
| Decision Date | 1993-05-17 |