Clearance Summary
CLIPLOC SOFT TISSUE MARKER 18G/100MM (4), /130MM (5 1/8), /150MM (6), MODELS 12370, 12372, 12376 received FDA 510(k) clearance under submission number K033447, sponsored by Mri Devices Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2004-01-28.
- Submission: K033447
- Applicant / Sponsor: Mri Devices Corp.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4300
- Decision date: 2004-01-28
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.