510(k) Report

Devices descending from K991514

30 later devices reach Gebauer's Chloride Fine Nozze through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190161Ethyl Chloride Medium Jet Stream, Ethyl Chloride Fine Pinpoint spray, Ethyl Chloride…Gebauer Company20190—
+1K031036Gebauer's Skin Refrigerant (Mist Spray), Model P/N 0386-0010-07, Gebauer's Skin…Gebauer Co.2003111
+1K021726Gebauer's Instant IceGebauer Co.2002292
+2K202782num Vapocoolant623 Medical, LLC20200—
+2K172203CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream SprayNuance Medical, LLC20170—
+2K033720Ari Cold SprayAri20050—
+2K032671Gebauer's Skin Refrigerant (Mist Stream), Gebauer's Skin Refrigerant (Stream Spray)…Gebauer Co.200493
+2K030281Cryotron 2 Cryotherapy DeviceCryonic Medical North America200314—
+3K203661CRYO Arctic, CRYO PenguinCryoscience North America, Inc.20220—
+3K172598Coventry Topical Anesthetic Mist Spray HAZMAT FREE, Coventry Topical Anesthetic Stream…Itw Contamination Control Electronics20180—
+3K172028Gebauer’s Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray)Gebauer Company20174—
+3K170810CryofosCryofos Medical GmbH201713—
+3K162218Pain Freeze™, Medium Stream Spray, Model #2101; Pain Freeze™, Mist Spray, Model #2102Nuance Medical, LLC20163—
+4K261684FreezeSpray TACryosurgery, Inc.20260—
+4K260870Gebauer's Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray)Gebauer Company20260—
+4K232674PainFreeze IINuance Medical, LLC20241—
+4K203481CryoVIVERecensmedical, Inc.20215—
+4K193349Vapocoolshot MistVapocoolshot, Inc.20201—
+4K182392Frozen CB.M. Tech. Worldwide Co., Ltd.20186—
+5K230599TargetCool™Recensmedical, Inc.20232—
+5K220674TargetCoolRecensmedical, Inc.20224—
+5K201260Dermal Cooling SystemR2 Technologies, Inc.20203—
+5K201248Syringe Holder accessoryVapocoolshot, Inc.20200—
+5K193665Frozen NYozma Bmtech Co., Ltd.20201—
+6K253114TargetCool™ (RM-DT02W)Recensmedical, Inc.20250—
+6K253348TargetCool-eRecensmedical, Inc.20250—
+6K221234TargetCoolRecensmedical, Inc.20223—
+6K203006R2 Dermabrasion Tip (for Dermal Cooling System)R2 Technologies, Inc.20212—
+7K213294Dermal Cooling SystemR2 Technologies, Inc.20221—
+8K253261Apollo Quattro (APQ-10M)Weero Co., Ltd.20260—