Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is Gebauer Company. It received FDA 510(k) clearance on 2017-10-27 under 510(k) 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. The listed applicant is Gebauer Company. The 510(k) number is K172028.

When did Gebauer’s Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray) receive FDA 510(k) clearance?

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

Who is the listed applicant for Gebauer’s Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray)?

The FDA 510(k) record lists Gebauer Company as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT04766684Clubfoot Tenotomy TrialCOMPLETEDNCT06228144Radio-Frequency Microneedling DeviceTERMINATEDNCT07548892Comparison of Needle-Free Injection and Conventional Syringe for Tooth Extractions in ChildrenNOT_YET_RECRUITINGNCT07563062Oropharyngeoesophageal Topical Anesthesia Versus Intravenous Propofol -Ketamine Sedation for Upper Gastrointestinal EndoscopyCOMPLETED

Other records listing Gebauer Company as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243654DentalJectVapocoolshot, Inc.K232674PainFreeze IINuance Medical, LLCK203661CRYO Arctic, CRYO PenguinCryoscience North America, Inc.K202782num Vapocoolant623 Medical, LLCK201248Syringe Holder accessoryVapocoolshot, Inc.K193349Vapocoolshot MistVapocoolshot, 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.

↑