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Cryoprobe CP-2004059

by Icecure Medical Ltd

Cryoprobe CP-2004059 is a Class II device made by Icecure Medical Ltd, cleared under FDA 510(k) K240892 on 28 Jun 2024 and listed in FDA GUDID since 6 May 2025 (UDI-DI 07290015487542), 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) K240892

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 Number07290015487542 UDI-DI Date6 May 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK240892 Date28 Jun 2024DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K240892 decided 28 Jun 2024 Active
  • FDA GUDID UDI-DI 07290015487542 listed 6 May 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K240892
  2. Listed FDA GUDID 07290015487542

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Cryoprobe
Generic name
Hand-held cryosurgical system handpiece tip
Model / reference
CP-2004059
Primary DI / UDI-DI
07290015487542
510(k) Number
FDA product code
GEH
GMDN term
Hand-held cryosurgical system handpiece tip
Device class
Class II
Regulation number
878.4350
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Size
Needle Gauge — 10 Gauge
Shaft Length — 140 Millimeter

Related devices

Category: Hand-held cryosurgical system handpiece tip

Cleared under the same submission (K240892)

Similar devices

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

Other devices from Icecure Medical Ltd.

See all devices from Icecure Medical Ltd. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (9, all answered No)