510(k) Report

Devices descending from K101561

3 later devices reach TX1 Tissue Removal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123640TX1 Tissue Removal SystemTenex Health201321
+2K153299Tenex Health TX SystemTenex Health, Inc.20161—
+3K212049Oclet TDS 1000Tendonova Corporation20220—