KSEA SEMI-RIGID HYSTEROSCOPE AND ACCESSORIES

KSEA SEMI-RIGID HYSTEROSCOPE AND ACCESSORIES is an FDA 510(k)-cleared medical device (K971518) 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 July 23, 1997. Regulation: 8.