FDA 510(k) Applications for Medical Device Product Code "MLY"
(Refrigerant, Topical (Vapocoolant))
FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K202782 |
623 Medical, LLC |
num Vapocoolant |
12/21/2020 |
K033720 |
ARI |
ARI COLD SPRAY |
06/10/2005 |
K030281 |
CRYONIC MEDICAL NORTH AMERICA |
CRYOTRON 2 CRYOTHERAPY DEVICE |
08/20/2003 |
K203661 |
CryoScience North America, Inc. |
CRYO Arctic, CRYO Penguin |
05/25/2022 |
K984564 |
DUKAL CORP. |
ETHYL CHLORIDE DISPENSER |
12/02/1999 |
K991514 |
GEBAUER CO. |
GEBAUER'S CHLORIDE FINE NOZZE |
07/16/1999 |
K001624 |
GEBAUER CO. |
GEBAUER'S FLUORI-METHANE, MODEL 0386-0003-04 |
01/25/2001 |
K002596 |
GEBAUER CO. |
GEBAUER'S FLURO ETHYL, MODEL 0386-0002-09 |
02/15/2001 |
K021726 |
GEBAUER CO. |
GEBAUER'S INSTANT ICE |
12/12/2002 |
K031036 |
GEBAUER CO. |
GEBAUER'S SKIN REFRIGERANT (MIST SPRAY), MODEL P/N 0386-0010-07, GEBAUER'S SKIN REFRIGERENT (MEDIUM SPRAY), MODEL P/N-03 |
07/10/2003 |
K032671 |
GEBAUER CO. |
GEBAUER'S SKIN REFRIGERANT (MIST STREAM), GEBAUER'S SKIN REFRIGERANT (STREAM SPRAY), MODELS P/N 0386-0010-07 |
03/17/2004 |
K190161 |
Gebauer Company |
Ethyl Chloride Medium Jet Stream, Ethyl Chloride Fine Pinpoint spray, Ethyl Chloride Mist, Ethyl Chloride Accustream 360* Medium Spray, Ethyl Chloride Accustream 360* Fine Spray |
05/07/2019 |
K172028 |
Gebauer Company |
GebauerÆs Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray) |
10/27/2017 |
K172598 |
ITW Contamination Control Electronics |
Coventry Topical Anesthetic Mist Spray HAZMAT FREE, Coventry Topical Anesthetic Stream Spray HAZMAT FREE |
04/19/2018 |
K172203 |
Nuance Medical, LLC |
CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream Spray |
10/18/2017 |
K162218 |
NUANCE MEDICAL, LLC |
Pain FreezeÖ, Medium Stream Spray, Model #2101; Pain FreezeÖ, Mist Spray, Model #2102 |
11/22/2016 |
K093951 |
OCCAM DESIGN |
OUCHLESS MODEL PN10114 |
06/15/2010 |
K992286 |
RHEALM PHARMACEUTICALS, INC. |
DERMAFREEZE |
01/21/2000 |
K201248 |
Vapocoolshot, Inc. |
Syringe Holder accessory |
08/12/2020 |
K193349 |
Vapocoolshot, Inc. |
Vapocoolshot Mist |
04/14/2020 |
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