KARL STORZ BOUGIES, SOUNDS, DILATORS

KARL STORZ BOUGIES, SOUNDS, DILATORS is an FDA 510(k)-cleared medical device (K946331) manufactured by KARL STORZ Endoscopy-America, Inc.. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 1, 1995. Regulation: 8.