510(k) K071754

NEO-VAGINA SURGERY SET AND ACCESSORIES by KARL STORZ Endoscopy-America, Inc. — Product Code HDX

K071754 is an FDA 510(k) premarket notification submitted by KARL STORZ Endoscopy-America, Inc. for the device "NEO-VAGINA SURGERY SET AND ACCESSORIES". The FDA issued a decision of Substantially Equivalent on January 7, 2009. The device falls under product code HDX (Dilator, Vaginal), a Class II device regulated under 21 CFR 884.3900. KARL STORZ Endoscopy-America, Inc. has at least 10 other 510(k) clearances on record.