The following data is part of a premarket notification filed by Unisurge, Inc. with the FDA for Unisurge Disposable Trocar.
| Device ID | K914923 |
| 510k Number | K914923 |
| Device Name: | UNISURGE DISPOSABLE TROCAR |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | UNISURGE, INC. 1963 ROCK ST. SUITE 17 Mountain View, CA 94043 |
| Contact | Charles L Rose |
| Correspondent | Charles L Rose UNISURGE, INC. 1963 ROCK ST. SUITE 17 Mountain View, CA 94043 |
| Product Code | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-04 |
| Decision Date | 1992-09-21 |