K100517 is an FDA 510(k) clearance for the INSTRUMED FORCEPS OBSTERICAL, MODEL# 46-5XXX, OB-XXXX, a Forceps, Obstetrical (Class II — Special Controls, product code HDA), submitted by Instrumed International, Inc. (Schaumburg, US). The FDA issued a Cleared decision on April 29, 2010, 65 days after receiving the submission on February 23, 2010. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4400.
| 510(k) Number | K100517 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 23, 2010 |
| Decision Date | April 29, 2010 |
| Days to Decision | 65 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HDA — Forceps, Obstetrical |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.4400 |