510(k) K935235

ENDOSCOPY SYSTEM FOR FACIAL PLASTIC SURGERY by Smith & Nephew Richards, Inc. — Product Code GCM

K935235 is an FDA 510(k) premarket notification submitted by Smith & Nephew Richards, Inc. for the device "ENDOSCOPY SYSTEM FOR FACIAL PLASTIC SURGERY". The FDA issued a decision of Substantially Equivalent on March 23, 1995. The device falls under product code GCM (Endoscope, Rigid), a Class II device regulated under 21 CFR 876.1500. Smith & Nephew Richards, Inc. has at least 10 other 510(k) clearances on record.