Clearance Summary
3-RING HANDLE, GRASP FORCEPS, LOOP RETRIE., BASKET received FDA 510(k) clearance under submission number K894986, sponsored by North American Sterilization & Packaging Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 1989-12-01.
- Submission: K894986
- Applicant / Sponsor: North American Sterilization & Packaging Co.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 1989-12-01
Classification & Regulation
This clearance is catalogued under FDA product code OCZ and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.