Clearance Summary
COLONOSCOPIC INJECTION NEEDLE, C-323/C-325 received FDA 510(k) clearance under submission number K921800, sponsored by Mill-Rose Laboratory. 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 1993-02-08.
- Submission: K921800
- Applicant / Sponsor: Mill-Rose Laboratory
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 1993-02-08
Classification & Regulation
This clearance is catalogued under FDA product code FBK and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.