K810391 is an FDA 510(k) clearance for the VOGLER HYSTERECTOMY FORCEPS (SMALL & LG). This device is classified as a Forceps, Surgical, Gynecological (Class II - Special Controls, product code HCZ).
Submitted by Edward Weck, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 4, 1981, 15 days after receiving the submission on February 17, 1981.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4530.
| 510(k) Number | K810391 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 17, 1981 |
| Decision Date | March 04, 1981 |
| Days to Decision | 15 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | — |
| Product Code | HCZ — Forceps, Surgical, Gynecological |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.4530 |