510(k) K261684

Device
FreezeSpray TA
Applicant
Cryosurgery, Inc.
510(k) number
K261684
Product code
MLY
Decision
Substantially Equivalent (SESE)
Decision date
2026-09-05
Date received
2026-05-21
Classification name
Vapocoolant Device
Medical specialty
Unknown
Review panel
Unknown
Device class
U
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Ronald McDow
Address
5829 Old Harding Pike Nashville TN US 37205 37205

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
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K172028Gebauer’s Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray)Gebauer Company2017-10-27
K172203CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream SprayNuance Medical, LLC2017-10-18
K162218Pain Freeze™, Medium Stream Spray, Model #2101; Pain Freeze™, Mist Spray, Model #2102Nuance Medical, LLC2016-11-22
K093951OUCHLESS MODEL PN10114Occam Design2010-06-15
K033720ARI COLD SPRAYAri2005-06-10
K032671GEBAUER'S SKIN REFRIGERANT (MIST STREAM), GEBAUER'S SKIN REFRIGERANT (STREAM SPRAY), MODELS P/N 0386-0010-07Gebauer Co.2004-03-17