510(k) K950639

KARL STORZ INFANT, BALLOON VAGINOSCOPE, VAGINOSCOPE SHEATH, FIBER OPTIC LIGHT CARRIERS, ADJUSTABLE MAGNIFIERS by KARL STORZ Endoscopy-America, Inc. — Product Code MOK

K950639 is an FDA 510(k) premarket notification submitted by KARL STORZ Endoscopy-America, Inc. for the device "KARL STORZ INFANT, BALLOON VAGINOSCOPE, VAGINOSCOPE SHEATH, FIBER OPTIC LIGHT CARRIERS, ADJUSTABLE MAGNIFIERS". The FDA issued a decision of Substantially Equivalent on June 19, 1995. The device falls under product code MOK (Vaginoscope And Accessories), a Class II device regulated under 21 CFR 884.1630. KARL STORZ Endoscopy-America, Inc. has at least 10 other 510(k) clearances on record.