Clearance Summary
KODNER ANAL PERIONEAL RETRACTOR received FDA 510(k) clearance under submission number K870897, sponsored by Sur-Med Instruments, 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 1987-06-04.
- Submission: K870897
- Applicant / Sponsor: Sur-Med Instruments, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.4730
- Decision date: 1987-06-04
Classification & Regulation
This clearance is catalogued under FDA product code FFO and 21 CFR 876.4730, within the Gastroenterology, Urology review panel as a Class I device.