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)

Syringe Holder accessory

K-Number: K201248 · 2020-08-12

ApplicantVapocoolshot, Inc.
Decision Date2020-08-12
Product CodeMLY
DecisionSubstantially Equivalent

Device Summary

Syringe Holder accessory is the device name listed in this FDA 510(k) record. The listed applicant is Vapocoolshot, Inc.. It received FDA 510(k) clearance on 2020-08-12 under 510(k) number K201248. The device is classified under product code MLY. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Syringe Holder accessory?

Syringe Holder accessory is a medical device that received FDA 510(k) clearance on 2020-08-12. The listed applicant is Vapocoolshot, Inc.. The 510(k) number is K201248.

When did Syringe Holder accessory receive FDA 510(k) clearance?

Syringe Holder accessory received FDA 510(k) clearance on 2020-08-12, under 510(k) number K201248.

Who is the listed applicant for Syringe Holder accessory?

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

What is the FDA product code for Syringe Holder accessory?

The FDA product code for Syringe Holder accessory is MLY.

Other records listing Vapocoolshot, Inc. 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.

K243654DentalJectK193349Vapocoolshot Mist

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, LLCK193349Vapocoolshot MistVapocoolshot, Inc.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

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.

↑