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Cryo 6 7342

by Zimmer MedizinSysteme GmbH

Cryo 6 7342 is a Class II device made by Zimmer MedizinSysteme GmbH, cleared under FDA 510(k) K060395 on 24 Feb 2006 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 04053815044635), active as of 22 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 22 Oct 2026

Documents

510(k) K060395

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04053815044635 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK060395 Date24 Feb 2006DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K060395 decided 24 Feb 2006 Active
  • FDA GUDID UDI-DI 04053815044635 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K060395
  2. Listed FDA GUDID 04053815044635

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Cryo 6
Generic name
Localized cutaneous/musculoskeletal cryotherapy unit
Model / Ref / Catalog
7342
Primary DI / UDI-DI
04053815044635
510(k) Number
FDA product code
GEX
GMDN term
Localized cutaneous/musculoskeletal cryotherapy unit
Device class
Class II
Regulation number
878.4810
GUDID distribution status
In Commercial Distribution

Related devices

Category: Localized cutaneous/musculoskeletal cryotherapy unit

Cleared under the same submission (K060395)

Similar devices

Other devices filed under FDA product code GEX (Powered Laser Surgical Instrument).

Other devices from Zimmer Medizinsystems GmbH

See all devices from Zimmer Medizinsystems GmbH →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)