NEO-VAGINA SURGERY SET AND ACCESSORIES

NEO-VAGINA SURGERY SET AND ACCESSORIES is an FDA 510(k)-cleared medical device (K071754) manufactured by KARL STORZ Endoscopy-America, Inc.. This device is classified under the Obstetrics/Gynecology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 6, 2009. Regulation: 8.