
Gabris Surgical Corp.
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LAPAROSCOPIC SURGICAL INSTRUMENT/ACCESSORY KIT is an FDA 510(k)-cleared medical device (K944640) manufactured by Gabris Surgical Corp.. 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 October 10, 1994. Regulation: 8.