Clearance Summary
COOK LAPAROSCOPIC MINI RETRACTOR SET received FDA 510(k) clearance under submission number K936026, sponsored by Cook Urological, 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 1994-03-11.
- Submission: K936026
- Applicant / Sponsor: Cook Urological, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4160
- Decision date: 1994-03-11
Classification & Regulation
This clearance is catalogued under FDA product code HFI and 21 CFR 884.4160, within the Obstetrics/Gynecology review panel as a Class II device.