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cryoICE® CRYO3

by Atricure, Inc.

cryoICE® CRYO3 (A001561) is a Class II device made by Atricure, Inc., cleared under FDA 510(k) K180137 on 15 Feb 2018 and listed in FDA GUDID since 29 Sep 2026 (UDI-DI 10840143912795), 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) K180137

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 Number10840143912795 UDI-DI Date29 Sep 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK180137 Date15 Feb 2018DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K180137 decided 15 Feb 2018 Active
  • FDA GUDID UDI-DI 10840143912795 listed 29 Sep 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K180137
  2. Listed FDA GUDID 10840143912795

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  • Withdrawn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
CRYO3, A001561
Primary DI / UDI-DI
10840143912795
510(k) Number
FDA product code
GEH
GMDN term
General cryosurgical system, cryogen gas, mechanical
Device class
Class II
Regulation number
878.4350
GUDID distribution status
In Commercial Distribution
Size
Length — 10 Centimeter

Related devices

Cleared under the same submission (K180137)

and 4 more cleared under K180137

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)