Syringe Holder accessory

Q: What is the product code of K201248?

The FDA product code is MLY – Vapocoolant Device, a Unclassified device.

FDA 510(k) K201248 · Vapocoolshot, Inc.

Substantially Equivalent

510(k) numberK201248

Submission

Device name: Syringe Holder accessory
Applicant: Vapocoolshot, Inc.
Jupiter, FL, US
Received: May 11, 2020
Decision date: August 12, 2020
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: MLY – Vapocoolant Device
Device class: Unclassified

Other 510(k)s with product code MLY

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K261684	FreezeSpray TAMLY · Traditional	Cryosurgery, Inc.	09/05/2026SE
K260870	Gebauer's Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray)MLY · Traditional	Gebauer Company	08/27/2026SE
K243654	DentalJectMLY · Traditional	Vapocoolshot, Inc.	05/30/2025SE
K232674	PainFreeze IIMLY · Traditional	Nuance Medical, LLC	02/12/2024SE
K203661	CRYO Arctic, CRYO PenguinMLY · Traditional	Cryoscience North America, Inc.	05/25/2022SE
K202782	num VapocoolantMLY · Traditional	623 Medical, LLC	12/21/2020SE
K193349	Vapocoolshot MistMLY · Traditional	Vapocoolshot, Inc.	04/14/2020SE
K190161	Ethyl Chloride Medium Jet Stream, Ethyl Chloride Fine Pinpoint spray, Ethyl Chloride…MLY · Traditional	Gebauer Company	05/07/2019SE
K172598	Coventry Topical Anesthetic Mist Spray HAZMAT FREE, Coventry Topical Anesthetic Stream…MLY · Traditional	Itw Contamination Control Electronics	04/19/2018SE
K172028	Gebauers Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray)MLY · Traditional	Gebauer Company	10/27/2017SE

More from Gebauer Company

510(k)	Device	Decision
K243654	DentalJectMLY · Traditional	05/30/2025SE
K193349	Vapocoolshot MistMLY · Traditional	04/14/2020SE

Questions and answers

When was Syringe Holder accessory cleared by the FDA?

Syringe Holder accessory (K201248) received a 510(k) decision of Substantially Equivalent on August 12, 2020, 93 days after the submission was received.

What is the product code of K201248?

The FDA product code is MLY – Vapocoolant Device, a Unclassified device.