Clearance Summary
HYSTERO CO2-PNEU 2221 received FDA 510(k) clearance under submission number K964136, sponsored by Richard Wolf Medical Instruments Corp.. 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 1997-01-10.
- Submission: K964136
- Applicant / Sponsor: Richard Wolf Medical Instruments Corp.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1700
- Decision date: 1997-01-10
Classification & Regulation
This clearance is catalogued under FDA product code HIG and 21 CFR 884.1700, within the Obstetrics/Gynecology review panel as a Class II device.