Clearance Summary
PAJUNK DISPOSABLE BALLOONS AND BALLOON SYSTEMS received FDA 510(k) clearance under submission number K090631, sponsored by PAJUNK GmbH Medizintechnologie. 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 2009-04-16.
- Submission: K090631
- Applicant / Sponsor: PAJUNK GmbH Medizintechnologie
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2009-04-16
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.