Clearance Summary
MICROENDOSCOPE MODEL S-0001 SINGLE LIGHT SOURCE, MICROENDOSCOPE, MODEL D-0001 DUAL LIGHT SOURCE STERILE received FDA 510(k) clearance under submission number K092739, sponsored by C-Link Micro Imaging, Inc.. 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 2010-01-12.
- Submission: K092739
- Applicant / Sponsor: C-Link Micro Imaging, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2010-01-12
Classification & Regulation
This clearance is catalogued under FDA product code ODF and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.