Clearance Summary
RECTAL SPECULA - CHELSEA-EATON, KELLY, MATHIEU received FDA 510(k) clearance under submission number K892542, sponsored by Zinnanti Surgical 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 1989-05-09.
- Submission: K892542
- Applicant / Sponsor: Zinnanti Surgical Instruments, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.4730
- Decision date: 1989-05-09
Classification & Regulation
This clearance is catalogued under FDA product code FFN and 21 CFR 876.4730, within the Gastroenterology, Urology review panel as a Class I device.