Clearance Summary
8 GAUGE MICROMARK II TISSUE MARKER, MODELS C1540 & C1535 received FDA 510(k) clearance under submission number K020276, sponsored by Ethicon Endo-Surgery, Inc.. 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 2002-04-12.
- Submission: K020276
- Applicant / Sponsor: Ethicon Endo-Surgery, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4300
- Decision date: 2002-04-12
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.