
Suros Surgical Systems, Inc. A Hologic Company
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SECURMARK BIOPSY SITE MARKING SYSTEM is an FDA 510(k)-cleared medical device (K102608) manufactured by Suros Surgical Systems, Inc. A Hologic Company. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 7, 2010. Regulation: 8.