K042603 is an FDA 510(k) clearance for the GYNECARE PROLENE FASTENER SYSTEM. This device is classified as a Fixation, Non-absorbable Or Absorbable, For Pelvic Use (Class II - Special Controls, product code PBQ).
Submitted by Ethicon, Inc. (Somerville, US). The FDA issued a Cleared decision on December 22, 2004, 89 days after receiving the submission on September 24, 2004.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4530. Attaching Suture Or Stapling Ligaments Of The Pelvic Floor..
| 510(k) Number | K042603 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 24, 2004 |
| Decision Date | December 22, 2004 |
| Days to Decision | 89 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | PBQ — Fixation, Non-absorbable Or Absorbable, For Pelvic Use |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.4530 |
| Definition | Attaching Suture Or Stapling Ligaments Of The Pelvic Floor. |