510(k) K213783
K213783 is an FDA 510(k) premarket notification submitted by Escala Medical for the device "Apyx". The FDA issued a decision of Substantially Equivalent on April 5, 2022. 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. Escala Medical has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 5, 2022
- Date Received
- December 3, 2021
- 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.