510(k) K934315

ENDOVATIONS(R) .035 PRE-CUT PAPILLATOME by Endovations — Product Code KNS

K934315 is an FDA 510(k) premarket notification submitted by Endovations for the device "ENDOVATIONS(R) .035 PRE-CUT PAPILLATOME". The FDA issued a decision of Substantially Equivalent on February 28, 1994. The device falls under product code KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories)), a Class II device regulated under 21 CFR 876.4300. Endovations has at least 10 other 510(k) clearances on record.