K920549 is an FDA 510(k) clearance for the SHARPE ENDONEEDLE HOLDER, a Laparoscope, Gynecologic (and Accessories) (Class II — Special Controls, product code HET), submitted by Paladin Medical, Inc. (Stillwater, US). The FDA issued a Cleared decision on September 22, 1992, 229 days after receiving the submission on February 6, 1992. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1720.
| 510(k) Number | K920549 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 06, 1992 |
| Decision Date | September 22, 1992 |
| Days to Decision | 229 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HET — Laparoscope, Gynecologic (and Accessories) |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.1720 |