ASI CYSTOLASE LASER CYSTOSCOPE

ASI CYSTOLASE LASER CYSTOSCOPE is an FDA 510(k)-cleared medical device (K930361) manufactured by Advanced Surgical Intervention, 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 April 28, 1993. Regulation: 8.