
KARL STORZ Endoscopy-America, Inc.
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CALCULASE II is an FDA 510(k)-cleared medical device (K140964) manufactured by KARL STORZ Endoscopy-America, 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 September 3, 2014. Regulation: 8.