
American Edwards Laboratories
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URETERAL STONE EXTRACTOR CATHETER is an FDA 510(k)-cleared medical device (K831244) manufactured by American Edwards Laboratories. 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 June 16, 1983. Regulation: 8.