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Cryotron 2 Cryotherapy Device

by Cryonic Medical North America

510(k) K030281

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K030281↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK030281 Date20 Aug 2003ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
MLY
Device Class
U
Advisory Committee
Unknown
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Cryotron 2 Cryotherapy Device is a vapocoolant device used for cryotherapy applications. It is designed to deliver controlled cooling for therapeutic purposes.

This device is supplied as a reusable system and has received FDA 510(k) clearance (K030281) and MDR authorization. It is manufactured by Cryonic Medical North America and is intended for use in clinical settings where cryotherapy is indicated.

Questions

AI-generated answers, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Cryotron 2 Cryotherapy Device used for?

    The Cryotron 2 Cryotherapy Device is a vapocoolant device designed to deliver controlled cooling for therapeutic cryotherapy applications in clinical settings where such treatment is indicated.

  • Is the Cryotron 2 Cryotherapy Device reusable or single-use?

    The Cryotron 2 Cryotherapy Device is supplied as a reusable system, meaning it is intended for multiple uses after appropriate cleaning and maintenance between treatments.

  • What regulatory authorizations does the Cryotron 2 Cryotherapy Device have?

    The Cryotron 2 Cryotherapy Device has received FDA 510(k) clearance under K030281 and MDR authorization, as stated in the device data.