K003608 is an FDA 510(k) clearance for the SOVEREIGN BIPOLAR INSTRUMENTS FOR GYNECOLOGY. This device is classified as a Electrocautery, Gynecologic (and Accessories) (Class II - Special Controls, product code HGI).
Submitted by Aesculap, Inc. (Allentown, US). The FDA issued a Cleared decision on February 20, 2001, 90 days after receiving the submission on November 22, 2000.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4120.
| 510(k) Number | K003608 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 22, 2000 |
| Decision Date | February 20, 2001 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HGI — Electrocautery, Gynecologic (and Accessories) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.4120 |