Clearance Summary
FORCEPS, BIOPSY, GASTROINTESTINAL received FDA 510(k) clearance under submission number K934186, sponsored by Primed 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 1993-12-14.
- Submission: K934186
- Applicant / Sponsor: Primed Instruments, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.1075
- Decision date: 1993-12-14
Classification & Regulation
This clearance is catalogued under FDA product code FCL and 21 CFR 876.1075, within the Gastroenterology, Urology review panel as a Class I device.