
Surgical Instrument Service and Savings, Inc.
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Medline ReNewal Reprocessed Carter-Thomason Needle Point Suture Passer is an FDA 510(k)-cleared medical device (K182828) manufactured by Surgical Instrument Service and Savings, Inc.. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 14, 2019. Regulation: 8.