Clearance Summary
G-CATH TISSUE ANCHOR DELIVERY CATHETER, MODELS 205302, 205333 received FDA 510(k) clearance under submission number K100251, sponsored by Usgi Medical. 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 2010-02-17.
- Submission: K100251
- Applicant / Sponsor: Usgi Medical
- Clearance pathway: Special
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.5000
- Decision date: 2010-02-17
Classification & Regulation
This clearance is catalogued under FDA product code GAT and 21 CFR 878.5000, within the General, Plastic Surgery review panel as a Class II device.