Clearance Summary
ENDOSCOPIC ACCESSORY TO THE LIGHT SOURCE received FDA 510(k) clearance under submission number K905282, sponsored by Frantz Medical Development, Ltd.. 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 1991-03-19.
- Submission: K905282
- Applicant / Sponsor: Frantz Medical Development, Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 1991-03-19
Classification & Regulation
This clearance is catalogued under FDA product code GCT and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.