Clearance Summary
SECURMARK BIOPSY SITE MARKING SYSTEM received FDA 510(k) clearance under submission number K102608, sponsored by Suros Surgical Systems, Inc. A Hologic Company. 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 2010-10-08.
- Submission: K102608
- Applicant / Sponsor: Suros Surgical Systems, Inc. A Hologic Company
- Clearance pathway: Special
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4300
- Decision date: 2010-10-08
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.