Clearance Summary
GIBBONS STERILE TROCAR KITS received FDA 510(k) clearance under submission number K012198, sponsored by Gibbons Surgical Corp.. The device was reviewed via the Special premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2001-08-09.
- Submission: K012198
- Applicant / Sponsor: Gibbons Surgical Corp.
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5090
- Decision date: 2001-08-09
Classification & Regulation
This clearance is catalogued under FDA product code FBQ and 21 CFR 876.5090, within the Gastroenterology, Urology review panel as a Class II device.