Cleared Special

IceSphere 1.5 CX Cryoablation Needle (K181741) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K181741 · Galil Medical , Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2018
Decision
28d
Days
Class 2
Risk

K181741 is an FDA 510(k) clearance for the IceSphere 1.5 CX Cryoablation Needle. Classified as Unit, Cryosurgical, Accessories (product code GEH), Class II - Special Controls.

Submitted by Galil Medical , Ltd. (Yokneam, IL). The FDA issued a Cleared decision on July 30, 2018 after a review of 28 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4350 - the FDA general and plastic surgery device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Galil Medical , Ltd. devices

Submission Details

510(k) Number K181741 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2018
Decision Date July 30, 2018
Days to Decision 28 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 115d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code GEH Unit, Cryosurgical, Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4350
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Consultant

Galil Medical, Inc.
Stacey Bucklund

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - GEH Unit, Cryosurgical, Accessories

All 65
Devices cleared under the same product code (GEH) and FDA review panel - the closest regulatory comparables to K181741.
CryoTouch
K183601 · Cryoconcepts LP · Apr 2019
ClariFix
K190356 · Arrinex, Inc. · Feb 2019
Frozen C
K182392 · B.M. Tech. Worldwide Co., Ltd. · Oct 2018
ICEfx Cryoablation System
K181153 · Galil Medical, Inc. · May 2018
Freezpoint
K180211 · Bovie Medical Corp. · Mar 2018
AtriCure cryoICE cryo-ablation probe (CRYO3), AtriCure cryoICE cryoFORM cryo-ablation probe (CRYOF)
K180137 · AtriCure, Inc. · Feb 2018