Clearance Summary
GYNESURG received FDA 510(k) clearance under submission number K780587, sponsored by Polamedco, Inc.. 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 1978-05-25.
- Submission: K780587
- Applicant / Sponsor: Polamedco, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4530
- Decision date: 1978-05-25
Classification & Regulation
This clearance is catalogued under FDA product code KNA and 21 CFR 884.4530, within the Obstetrics/Gynecology review panel as a Class II device.