Clearance Summary
Apyx received FDA 510(k) clearance under submission number K213783, sponsored by Escala Medical. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2022-04-05.
- Submission: K213783
- Applicant / Sponsor: Escala Medical
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4530
- Decision date: 2022-04-05
Classification & Regulation
This clearance is catalogued under FDA product code PBQ and 21 CFR 884.4530, within the Obstetrics/Gynecology review panel as a Class II device.