510(k) K083788

ENDO OPTIKS UROLOGICAL CATHETER FOR ENDOSCOPY, MODEL SESSR by Endooptiks, Inc. — Product Code EYB

K083788 is an FDA 510(k) premarket notification submitted by Endooptiks, Inc. for the device "ENDO OPTIKS UROLOGICAL CATHETER FOR ENDOSCOPY, MODEL SESSR". The FDA issued a decision of Substantially Equivalent on March 3, 2009. The device falls under product code EYB (Catheter, Ureteral, Gastro-Urology), a Class II device regulated under 21 CFR 876.5130. Endooptiks, Inc. has at least 4 other 510(k) clearances on record.