510(k) K950495

SUGICAL DYNAMICS ENDOSCOPY IRRIGATION PUMP, CATALOG #3-4000 by Surgical Dynamics, Inc. — Product Code BTA

K950495 is an FDA 510(k) premarket notification submitted by Surgical Dynamics, Inc. for the device "SUGICAL DYNAMICS ENDOSCOPY IRRIGATION PUMP, CATALOG #3-4000". The FDA issued a decision of Substantially Equivalent on May 9, 1995. The device falls under product code BTA (Pump, Portable, Aspiration (Manual Or Powered)), a Class II device regulated under 21 CFR 878.4780. Surgical Dynamics, Inc. has at least 10 other 510(k) clearances on record.