Clearance Summary
PRECISION ENDOSCOPIC INFRARED COAGULATOR; MODEL 5100 SINGLE-USE DISPOSABLE MAXI-GUIDE FLEXIBLE LIGHTGUIDE; MODEL 5100-2 received FDA 510(k) clearance under submission number K122593, sponsored by Optim, LLC. 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 2012-09-13.
- Submission: K122593
- Applicant / Sponsor: Optim, LLC
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.4300
- Decision date: 2012-09-13
Classification & Regulation
This clearance is catalogued under FDA product code FEH and 21 CFR 876.4300, within the Gastroenterology, Urology review panel as a Class II device.