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Uroplasty, Inc.
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I-STOP MID-URETHRAL SLING, MODELS IS-1000, IS-2000, IS-3000, IS-4000 is an FDA 510(k)-cleared medical device (K052175) manufactured by Uroplasty, Inc.. 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 16, 2005. Regulation: 8.