Clearance Summary
RANDALL KIDNEY STONE FORCEPS 817-144 PCS. FULL CUR received FDA 510(k) clearance under submission number K851113, sponsored by The Huxley Instrument Corp.. 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 1985-04-03.
- Submission: K851113
- Applicant / Sponsor: The Huxley Instrument Corp.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.4730
- Decision date: 1985-04-03
Classification & Regulation
This clearance is catalogued under FDA product code KOA and 21 CFR 876.4730, within the Gastroenterology, Urology review panel as a Class I device.