The following data is part of a premarket notification filed by American Surgical Instruments Corp. with the FDA for Disposable Unipolar Coagulator Probe System.
| Device ID | K921716 |
| 510k Number | K921716 |
| Device Name: | DISPOSABLE UNIPOLAR COAGULATOR PROBE SYSTEM |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | AMERICAN SURGICAL INSTRUMENTS CORP. 430 COMMERCE DRIVE, SUITE 50E Delray Beach, FL 33445 |
| Contact | Dorsey, Iii |
| Correspondent | Dorsey, Iii AMERICAN SURGICAL INSTRUMENTS CORP. 430 COMMERCE DRIVE, SUITE 50E Delray Beach, FL 33445 |
| Product Code | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-09 |
| Decision Date | 1993-11-08 |