Clearance Summary
SURGIFLATOR-40 received FDA 510(k) clearance under submission number K001533, sponsored by W.O.M. Gmhb. The device was reviewed via the Special premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2000-07-31.
- Submission: K001533
- Applicant / Sponsor: W.O.M. Gmhb
- Clearance pathway: Special
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1730
- Decision date: 2000-07-31
Classification & Regulation
This clearance is catalogued under FDA product code HIF and 21 CFR 884.1730, within the Obstetrics/Gynecology review panel as a Class II device.