About This 510(k) Submission
K950639 is an FDA 510(k) clearance for the KARL STORZ INFANT, BALLOON VAGINOSCOPE, VAGINOSCOPE SHEATH, FIBER OPTIC LIGHT CARRIERS, ADJUSTABLE MAGNIFIERS, a Vaginoscope And Accessories (Class II — Special Controls, product code MOK), submitted by KARL STORZ Endoscopy-America, Inc. (Culver City, US). The FDA issued a Cleared decision on June 19, 1995, 126 days after receiving the submission on February 13, 1995. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1630.