Clearance Summary
MEDISISS REPROCESSED NON-ELECTRIC GI BIOPSY FORCEPS received FDA 510(k) clearance under submission number K042659, sponsored by Medisiss. 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 2005-02-14.
- Submission: K042659
- Applicant / Sponsor: Medisiss
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.1075
- Decision date: 2005-02-14
Classification & Regulation
This clearance is catalogued under FDA product code NON and 21 CFR 876.1075, within the Gastroenterology, Urology review panel as a Class I device.