510(k) Report

Devices descending from K243052

1 later device reach Glean Urodynamics System Male Delivery System (GUS-1000-M); Glean Urodynamics… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253537Glean Urodynamics System Male Delivery System (GUS-1000-M); Glean Urodynamics System…Bright Uro, Inc.20260—