Anesthesiology
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- MiscellaneousMiscellaneous
- LDKDevice, Sensing, Optical ContourUProduct Code
- LWBStimulator, Functional Neuromuscular, Scoliosis3Product Code
- LXMManipulator, Plunger-Like JointUProduct Code
- LZWMonitor, Spine CurvatureUProduct Code
- MBQPeripheral Electromagnetic Field (Pemf) To Aid Wound Healing3Product Code
- MLYVapocoolant DeviceUProduct Code
- K232674PainFreeze IIUCleared 510(K)
- K203661CRYO Arctic, CRYO PenguinUCleared 510(K)
- K202782num VapocoolantUCleared 510(K)
- K201248Syringe Holder accessoryUCleared 510(K)
- K193349Vapocoolshot MistUCleared 510(K)
- K190161Ethyl Chloride Medium Jet Stream, Ethyl Chloride Fine Pinpoint spray, Ethyl Chloride Mist, Ethyl Chloride Accustream 360* Medium Spray, Ethyl Chloride Accustream 360* Fine SprayUCleared 510(K)
- K172598Coventry Topical Anesthetic Mist Spray HAZMAT FREE, Coventry Topical Anesthetic Stream Spray HAZMAT FREEUCleared 510(K)
- K172028Gebauer’s Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray)UCleared 510(K)
- K172203CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream SprayUCleared 510(K)
- K162218Pain Freeze™, Medium Stream Spray, Model #2101; Pain Freeze™, Mist Spray, Model #2102UCleared 510(K)
Show All 22 Submissions
- QPYStimulator, Autonomic Nerve, Implanted For Stroke Rehabilitation3Product Code
- QWIComputerized Behavioral Therapy Device For The Treatment Of Fibromyalgia Symptoms2Product Code
- SDOTranscutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation2Product Code
- SECWearable Fall Injury Prevention Device2Product Code
- Submissions with No Product CodeMiscellaneous
- Subpart B—Physical Medicine Diagnostic DevicesCFR Sub-Part
- Subpart D—Physical Medicine Prosthetic DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- RadiologyReview Panel
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- UnknownReview Panel
Pain Freeze™, Medium Stream Spray, Model #2101; Pain Freeze™, Mist Spray, Model #2102
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K162218
- 510(k) Type
- Traditional
- Applicant
- NUANCE MEDICAL, LLC
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 11/22/2016
- Days to Decision
- 106 days
- Submission Type
- Summary