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cryoICE® CRYO2

by Atricure, Inc.

cryoICE® CRYO2 (A001560) is a Class II device made by Atricure, Inc., cleared under FDA 510(k) K200697 on 23 Dec 2020 (1 earlier submission) and listed in FDA GUDID since 29 Sep 2026 (UDI-DI 10840143912788), 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

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10840143912788 UDI-DI Date29 Sep 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK200697 Date23 Dec 2020DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K200697 decided 23 Dec 2020 Active· +1 more in the status table
  • FDA GUDID UDI-DI 10840143912788 listed 29 Sep 2026 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K180138
  2. Cleared FDA 510(k) K200697
  3. Listed FDA GUDID 10840143912788

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
cryoICE®
Generic name
General cryosurgical system, cryogen gas, mechanical
Model / Ref / Catalog
CRYO2, A001560
Primary DI / UDI-DI
10840143912788
510(k) Number
FDA product code
GXH
GMDN term
General cryosurgical system, cryogen gas, mechanical
Device class
Class II
Regulation number
882.4250
GUDID distribution status
In Commercial Distribution
Size
Length — 10 Centimeter

Related devices

Cleared under the same submission (K180138)

Cleared under the same submission (K200697)

Other devices from Atricure, Inc.

See all devices from Atricure, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)