510(k) Report

Devices descending from K031538

3 later devices reach Endovive Initial Placement Peg Kit, Direct Pej Kit, and Peg Safety Kit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K150679EndoVive Initial Placement Standard PEG Kit with ENFit Connector, EndoVive Initial…Boston Scientific Corp201503
+1K061021Entake Standard and Safety Peg SystemConmedcorp2006128
+2K182248Aspire Venting TubeAspire Bariatrics, Inc.20180—