Clearance Summary
KAPP BARI-RING ENDOSCOPIC MARKER, MODEL K-9536 received FDA 510(k) clearance under submission number K072216, sponsored by Kapp Surgical Instrument, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2007-11-09.
- Submission: K072216
- Applicant / Sponsor: Kapp Surgical Instrument, Inc.
- Clearance pathway: Special
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4300
- Decision date: 2007-11-09
Classification & Regulation
This clearance is catalogued under FDA product code NEU and 21 CFR 878.4300, within the General, Plastic Surgery review panel as a Class II device.