Clearance Summary
OWENS BIOPSY FORCEPS received FDA 510(k) clearance under submission number K924224, sponsored by Owens Precision Systems, 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 1994-02-04.
- Submission: K924224
- Applicant / Sponsor: Owens Precision Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class I
- Regulation citation: 21 CFR 884.4530
- Decision date: 1994-02-04
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.