Clearance Summary
GYNE-SHEAR CERVICAL BIOPSY INSTRUMENT W/DISPIS TIP received FDA 510(k) clearance under submission number K852357, 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 1985-07-05.
- Submission: K852357
- Applicant / Sponsor: Gyneco, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class I
- Regulation citation: 21 CFR 884.4530
- Decision date: 1985-07-05
Classification & Regulation
This clearance is catalogued under FDA product code HFB and 21 CFR 884.4530, within the Obstetrics/Gynecology review panel as a Class I device.