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Cryo Professional UTM0200

by Koninklijke Utermöhlen N.V. 4 variants

Cryo Professional UTM0200 is a Class II device made by Koninklijke Utermöhlen N.V., cleared under FDA 510(k) K152203 on 6 Nov 2015 and listed in FDA GUDID since 26 Jun 2024 (UDI-DI 08717484790540), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K152203

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08717484790540 UDI-DI Date26 Jun 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK152203 Date6 Nov 2015DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K152203 decided 6 Nov 2015 Active
  • FDA GUDID UDI-DI 08717484790540 listed 26 Jun 2024 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K152203
  2. Listed FDA GUDID 08717484790540

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Cryo Professional
Generic name
Cryogenic spray, cutaneous
Model / reference
UTM0200
Primary DI / UDI-DI
08717484790540
510(k) Number
FDA product code
GEH
GMDN term
Cryogenic spray, cutaneous
Device class
Class II
Regulation number
878.4350
GUDID distribution status
In Commercial Distribution

Related devices

Category: Cryogenic spray, cutaneous

Cleared under the same submission (K152203)

and 5 more cleared under K152203

Similar devices

Other devices filed under FDA product code GEH (Unit, Cryosurgical, Accessories).

Other devices from Koninklijke Utermöhlen N.V.

See all devices from Koninklijke Utermöhlen N.V. →

Properties

  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)