Clearance Summary
COMEG OPTICAL STONE CRUSHING FORCEPS, COMEG VISUAL OBTURATORS FOR UROLOGY, COMEG OPTICAL BIOPSY FORCEPS received FDA 510(k) clearance under submission number K971202, sponsored by Comeg Endoskopie GmbH. 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 1997-05-27.
- Submission: K971202
- Applicant / Sponsor: Comeg Endoskopie GmbH
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 1997-05-27
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.