Clearance Summary
REUSABLE HANDLE FOR LAPAROSCOPIC INST. W/ROTATING received FDA 510(k) clearance under submission number K930571, sponsored by Numed Technologies, 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 1994-02-01.
- Submission: K930571
- Applicant / Sponsor: Numed Technologies, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4160
- Decision date: 1994-02-01
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.