510(k) Report

Devices descending from K031036

11 later devices reach Gebauer's Skin Refrigerant (Mist Spray), Model P/N 0386-0010-07, Gebauer's… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K202782num Vapocoolant623 Medical, LLC20200—
+1K032671Gebauer's Skin Refrigerant (Mist Stream), Gebauer's Skin Refrigerant (Stream Spray)…Gebauer Co.200493
+2K190161Ethyl Chloride Medium Jet Stream, Ethyl Chloride Fine Pinpoint spray, Ethyl Chloride…Gebauer Company20190—
+2K172598Coventry Topical Anesthetic Mist Spray HAZMAT FREE, Coventry Topical Anesthetic Stream…Itw Contamination Control Electronics20180—
+2K172028Gebauer’s Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray)Gebauer Company20174—
+2K162218Pain Freeze™, Medium Stream Spray, Model #2101; Pain Freeze™, Mist Spray, Model #2102Nuance Medical, LLC20163—
+3K261684FreezeSpray TACryosurgery, Inc.20260—
+3K260870Gebauer's Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray)Gebauer Company20260—
+3K232674PainFreeze IINuance Medical, LLC20241—
+3K193349Vapocoolshot MistVapocoolshot, Inc.20201—
+4K201248Syringe Holder accessoryVapocoolshot, Inc.20200—