510(k) K120831
K120831 is an FDA 510(k) premarket notification submitted by Neomedic International S.L. for the device "ANCHORSURE". The FDA issued a decision of Substantially Equivalent on October 12, 2012. 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. Neomedic International S.L. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 12, 2012
- Date Received
- March 19, 2012
- 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.