K952483 is an FDA 510(k) clearance for the LEEP SYSTEM 1000. This device is classified as a Electrocautery, Gynecologic (and Accessories) (Class II - Special Controls, product code HGI).
Submitted by CooperSurgical, Inc. (North Attleboro, US). The FDA issued a Cleared decision on October 6, 1995, 129 days after receiving the submission on May 30, 1995.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4120.
| 510(k) Number | K952483 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 30, 1995 |
| Decision Date | October 06, 1995 |
| Days to Decision | 129 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 |