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Icerod Plus 17g Cryoablation Needle, Icerod Plus 17g 90* Cryoablation Needle

by Galil Medical Ltd

510(k) K110946

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK110946 Date21 Jun 2011ClearedStatusActive

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Completed Z-0667-2021 FDA Class II initiated 18 Nov 2020
    • Completed Z-0666-2021 FDA Class II initiated 18 Nov 2020

    Complaint trend regarding needle shaft gas leaks.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
GEH
FDA applicant
Galil Medical , Ltd.
Device Class
Class II
Regulation
21 CFR Part 878.4350
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Icerod Plus 17G Cryoablation Needle is a cryosurgical accessory designed for use in cryoablation procedures, which involve the destruction of tissue through extreme cold. It is a sterile, single-use, disposable component intended for use with Galil Medical Cryoablation Systems during surgical procedures.

The device is supplied in a sterile condition and is intended for single-use only. It is used in general and plastic surgery settings, with regulatory authorization under FDA 510(k) clearance (K110946) and classified as a Class II medical device under regulation number 878.4350.

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Questions

AI-generated answers, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the ICEROD PLUS 17G Cryoablation Needle used for?

    The ICEROD PLUS 17G Cryoablation Needle is a cryosurgical accessory used in cryoablation procedures to destroy tissue through extreme cold. It is intended for use in general and plastic surgery settings with Galil Medical Cryoablation Systems.

  • Is the ICEROD PLUS 17G Cryoablation Needle sterile and single-use?

    Yes, the device is supplied in a sterile condition and is designed for single-use only. It is a disposable component and must not be reused to maintain sterility and prevent cross-contamination.

  • What regulatory authorization does the ICEROD PLUS 17G Cryoablation Needle have?

    The device has received FDA 510(k) clearance under K110946 and is classified as a Class II medical device under regulation number 878.4350. It was found substantially equivalent to a predicate device.