K134047 is an FDA 510(k) clearance for the JARIT GYNECOLOGICAL FORCEPS, MILTEX GYNECOLOGICAL FORCEPS, MEISTERHAND GYNECOLOICAL FORCEPS. This device is classified as a Forceps, Surgical, Gynecological (Class II - Special Controls, product code HCZ).
Submitted by Integra LifeSciences Corporation (York, US). The FDA issued a Cleared decision on April 11, 2014, 101 days after receiving the submission on December 31, 2013.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4530.
| 510(k) Number | K134047 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 31, 2013 |
| Decision Date | April 11, 2014 |
| Days to Decision | 101 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 |