510(k) Report

Devices descending from K133333

4 later devices reach Uni NPWT Foam Dressing Kit, Uni NPWT Foam Dressing Kit, Uni NPWT Foam Dressing… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K161570Theia NPWT Foam Wound Dressing Kit-Small, Theia NPWT Foam Wound Dressing Kit-Medium…Lc Medical Concepts, Inc.20162—
+1K150459FloSure Ventilation PatchSimex Medizintechnik GmbH20160—
+2K211277Theia NPWT Foam Wound Dressing KitClear Choice Therapeutics, Inc.20211—
+3K232379PREVENT KitClear Choice Therapeutics20240—