510(k) Report

Devices descending from K120415

8 later devices reach Cryo-Touch Iii through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123516Cryo-Touch IVMyoscience, Inc.201371
+2K133453IoveraMyoscience, Inc.20146—
+3K142866Myoscience iovera systemMyoscience, Inc.201551
+4K161835iovera systemMyoscience, Inc.20174—
+5K211334Iovera SystemPacira Pharmaceuticals, Inc.20212—
+5K173763iovera systemMyoscience, Inc.20182—
+6K243677iovera° SystemPacira Biosciences, Inc.20240—
+6K220656iovera SystemPacira Biosciences, Inc.20221—