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FDA 510(k)

Gebauer’s Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray)

K-Number: K172028 · 2017-10-27

ApplicantGebauer Company
Decision Date2017-10-27
Product CodeMLY
DecisionSubstantially Equivalent

Device Summary

Gebauer’s Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray) is a medical device manufactured by Gebauer Company. It received FDA 510(k) clearance on 2017-10-27 under approval number K172028. The device is classified under product code MLY. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Gebauer’s Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray)?

Gebauer’s Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray) is a medical device that received FDA 510(k) clearance on 2017-10-27. It is manufactured by Gebauer Company. The 510(k) number is K172028.

When was Gebauer’s Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray) approved by the FDA?

Gebauer’s Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray) received FDA 510(k) clearance on 2017-10-27, under approval number K172028.

What company makes Gebauer’s Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray)?

Gebauer’s Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray) is manufactured by Gebauer Company.

What is the FDA product code for Gebauer’s Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray)?

The FDA product code for Gebauer’s Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray) is MLY.

Related Clinical Trials

NCT04766684 Clubfoot Tenotomy Trial COMPLETED NCT07563062 Oropharyngeoesophageal Topical Anesthesia Versus Intravenous Propofol -Ketamine Sedation for Upper Gastrointestinal Endoscopy COMPLETED NCT07548892 Comparison of Needle-Free Injection and Conventional Syringe for Tooth Extractions in Children NOT_YET_RECRUITING NCT07379515 Effects of Topical Anesthesia Approaches on Dental Pain During and After Restorative Management of Dental Caries NOT_YET_RECRUITING

Other Devices by Gebauer Company

K190161Ethyl Chloride Medium Jet Stream, Ethyl Chloride Fine Pinpoint spray, Ethyl Chloride Mist, Ethyl Chloride Accustream 360* Medium Spray, Ethyl Chloride Accustream 360* Fine Spray

Related Devices (Code: MLY)

K162218Pain Freeze™, Medium Stream Spray, Model #2101; Pain Freeze™, Mist Spray, Model #2102Nuance Medical, LLC K172203CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream SprayNuance Medical, LLC K172598Coventry Topical Anesthetic Mist Spray HAZMAT FREE, Coventry Topical Anesthetic Stream Spray HAZMAT FREEItw Contamination Control Electronics K190161Ethyl Chloride Medium Jet Stream, Ethyl Chloride Fine Pinpoint spray, Ethyl Chloride Mist, Ethyl Chloride Accustream 360* Medium Spray, Ethyl Chloride Accustream 360* Fine SprayGebauer Company K202782num Vapocoolant623 Medical, LLC K201248Syringe Holder accessoryVapocoolshot, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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