Clearance Summary
CHAKOFF ENDOSCOPY received FDA 510(k) clearance under submission number K945421, sponsored by Stephen Chakoff, 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 1994-12-23.
- Submission: K945421
- Applicant / Sponsor: Stephen Chakoff, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.4530
- Decision date: 1994-12-23
Classification & Regulation
This clearance is catalogued under FDA product code FDG and 21 CFR 876.4530, within the Gastroenterology, Urology review panel as a Class I device.