510(k) Report

Devices descending from K210437

2 later devices reach Standard Bougie, 38 Fr. through their predicates, nearest generation first.

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