510(k) Report

Devices descending from K113728

4 later devices reach Surfuse Gel and Putty, Exfuse Gel and Putty through their predicates, nearest generation first.

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