K925333 is an FDA 510(k) clearance for the SINGLE USE TUNGSTEN WIRE LEE LOOP ELECTRODE, a Electrocautery, Gynecologic (and Accessories) (Class II — Special Controls, product code HGI), submitted by Aspen Labs (Englewood, US). The FDA issued a Cleared decision on September 27, 1994, 706 days after receiving the submission on October 21, 1992. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4120.
| 510(k) Number | K925333 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 21, 1992 |
| Decision Date | September 27, 1994 |
| Days to Decision | 706 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Statement |
| Product Code | HGI — Electrocautery, Gynecologic (and Accessories) |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.4120 |