Clearance Summary
4 SURE TM ENEMA BAG SET received FDA 510(k) clearance under submission number K922398, sponsored by Boston Pacific Medical, 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 1993-06-17.
- Submission: K922398
- Applicant / Sponsor: Boston Pacific Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.5210
- Decision date: 1993-06-17
Classification & Regulation
This clearance is catalogued under FDA product code FCE and 21 CFR 876.5210, within the Gastroenterology, Urology review panel as a Class I device.