Clearance Summary
53-100 TO 53-120 VARIOUS RECTAL SPECULA(SIMS, MATH received FDA 510(k) clearance under submission number K851797, sponsored by Artiberia. 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 1985-05-23.
- Submission: K851797
- Applicant / Sponsor: Artiberia
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.4730
- Decision date: 1985-05-23
Classification & Regulation
This clearance is catalogued under FDA product code FFQ and 21 CFR 876.4730, within the Gastroenterology, Urology review panel as a Class I device.