Clearance Summary
UNISURGE TISSUE COLLECTION SYSTEM FOR ENDOS SURG received FDA 510(k) clearance under submission number K914922, sponsored by Charles L. Rose and Co., 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 1992-03-26.
- Submission: K914922
- Applicant / Sponsor: Charles L. Rose and Co., Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 1992-03-26
Classification & Regulation
This clearance is catalogued under FDA product code GCJ and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.