510(k) K042603
K042603 is an FDA 510(k) premarket notification submitted by ETHICON, Inc. for the device "GYNECARE PROLENE FASTENER SYSTEM". The FDA issued a decision of Substantially Equivalent on December 22, 2004. The device falls under product code PBQ (Fixation, Non-Absorbable Or Absorbable, For Pelvic Use), a Class II device regulated under 21 CFR 884.4530. ETHICON, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 22, 2004
- Date Received
- September 24, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Fixation, Non-Absorbable Or Absorbable, For Pelvic Use
- Device Class
- Class II
- Regulation Number
- 884.4530
- Review Panel
- OB
- Submission Type
Attaching suture or stapling ligaments of the pelvic floor.