KARL STORZ 10.5 FR. FLEXIBLE HYSTEROSCOPE

KARL STORZ 10.5 FR. FLEXIBLE HYSTEROSCOPE is an FDA 510(k)-cleared medical device (K961605) 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 November 12, 1996. Regulation: 8.