Clearance Summary
UTERINE MANIPULATORS received FDA 510(k) clearance under submission number K812204, sponsored by Reznik Instruments. 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 1981-10-13.
- Submission: K812204
- Applicant / Sponsor: Reznik Instruments
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class I
- Regulation citation: 21 CFR 884.4520
- Decision date: 1981-10-13
Classification & Regulation
This clearance is catalogued under FDA product code KOH and 21 CFR 884.4520, within the Obstetrics/Gynecology review panel as a Class I device.