510(k) Report

Devices descending from K894861

4 later devices reach Wiltek Papillotome through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K990376Ballard Medical Products Faciletome Bow String PapillotomeBallard Medical Products19990—
+1K982557Bard Proforma and Apollo Pre-Curved PapillotomesBard Interventional Products Div.19981—
+1K963484Bard High Flow PapillotomeBard Interventional Products Div.19960—
+2K080946Conmed Axcess Papillotome Models AX4535, AX4535FXConmed Endoscopic Technologies, Inc.20080—