K903205 is an FDA 510(k) clearance for the AUTO SUTURE(R) ENDOSCOPIC CLAMP. This device is classified as a Forceps, Obstetrical (Class II - Special Controls, product code HDA).
Submitted by United States Surgical, A Division of Tyco Healthc (Norwalk, US). The FDA issued a Cleared decision on October 11, 1990, 83 days after receiving the submission on July 20, 1990.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4400.
| 510(k) Number | K903205 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 20, 1990 |
| Decision Date | October 11, 1990 |
| Days to Decision | 83 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | — |
| Product Code | HDA — Forceps, Obstetrical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.4400 |