510(k) K220420
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 10, 2022
- Date Received
- February 14, 2022
- 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.