Clearance Summary
CATHETER REGULAR received FDA 510(k) clearance under submission number K813488, sponsored by Accurate Surgical Instruments Co.. 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 1981-12-31.
- Submission: K813488
- Applicant / Sponsor: Accurate Surgical Instruments Co.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5630
- Decision date: 1981-12-31
Classification & Regulation
This clearance is catalogued under FDA product code FJS and 21 CFR 876.5630, within the Gastroenterology, Urology review panel as a Class II device.