510(k) K990376

BALLARD MEDICAL PRODUCTS FACILETOME BOW STRING PAPILLOTOME by Ballard Medical Products — Product Code KNS

K990376 is an FDA 510(k) premarket notification submitted by Ballard Medical Products for the device "BALLARD MEDICAL PRODUCTS FACILETOME BOW STRING PAPILLOTOME". The FDA issued a decision of Substantially Equivalent on May 3, 1999. The device falls under product code KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories)), a Class II device regulated under 21 CFR 876.4300. Ballard Medical Products has at least 10 other 510(k) clearances on record.