Clearance Summary
MASTER ENDOMET BIOPSY KIT W/PLAS CURE 3,4MM-4003,4 received FDA 510(k) clearance under submission number K853216, sponsored by Gyneco, 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 1986-04-02.
- Submission: K853216
- Applicant / Sponsor: Gyneco, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1175
- Decision date: 1986-04-02
Classification & Regulation
This clearance is catalogued under FDA product code HHK and 21 CFR 884.1175, within the Obstetrics/Gynecology review panel as a Class II device.