510(k) Report

Devices descending from K191885

3 later devices reach Standard Bougie through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K210437Standard Bougie, 38 Fr.Standard Bariatrics20212—
+2K222085Standard Tapered Bougie, 38 Fr.Standard Bariatrics, Inc.20220—
+2K212728Standard Bougie, 38 Fr. and Hand PumpStandard Bariatrics20210—