510(k) Report

Devices descending from K053319

5 later devices reach Allomatrix Custom through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K152077MaxiGenHans Biomed Corp.20160—
+1K113728Surfuse Gel and Putty, Exfuse Gel and PuttyHans Biomed Corp.20124—
+2K171568SurFuse Gel, SurFuse Putty, ExFuse Gel, ExFuse PuttyHans Biomed Corporation20180—
+2K151271BellaFuseHans Biomed Corp.20160—
+2K130235Surfuse II Gel, Surfuse II Putty, Exfuse II Gel, Exfuse II PuttyHans Biomed Corp.20140—