Clearance Summary
SUCTION TUBE received FDA 510(k) clearance under submission number K864770, sponsored by New England Surgical 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 1987-02-24.
- Submission: K864770
- Applicant / Sponsor: New England Surgical Instrument Corp.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5090
- Decision date: 1987-02-24
Classification & Regulation
This clearance is catalogued under FDA product code FFA and 21 CFR 876.5090, within the Gastroenterology, Urology review panel as a Class II device.