K092840 is an FDA 510(k) clearance for the INSTRUMED FORCEPS OBSTETRICAL/GYNAECOLOGICAL, a Forceps, Surgical, Gynecological (Class II — Special Controls, product code HCZ), submitted by Instrumed International, Inc. (Schaumburg, US). The FDA issued a Cleared decision on December 3, 2009, 79 days after receiving the submission on September 15, 2009. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4530.
| 510(k) Number | K092840 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 15, 2009 |
| Decision Date | December 03, 2009 |
| Days to Decision | 79 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HCZ — Forceps, Surgical, Gynecological |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.4530 |