IcePearl 2.1 CX 90° Needle, IcePearl 2.1 CX L 90° Needle, IcePearl 2.1 CX Needle, IceFORCE 2.1 CX 90° Needle, IceFORCE 2.1 CX L 90° Needle, IceFORCE 2.1 CX Needle
FDA 510(k) K203032 · Galil Medical, Inc.
510(k) numberK203032
Submission
- Device name
- IcePearl 2.1 CX 90° Needle, IcePearl 2.1 CX L 90° Needle, IcePearl 2.1 CX Needle, IceFORCE 2.1 CX 90° Needle, IceFORCE 2.1 CX L 90° Needle, IceFORCE 2.1 CX Needle
- Applicant
- Galil Medical, Inc.
Arden Hills, MN, US - Received
- October 5, 2020
- Decision date
- November 2, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GEH – Unit, Cryosurgical, Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4350
- Specialty
- General, Plastic Surgery
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| K261806 | ERBECRYO 2 Cryosurgical Unit and AccessoriesGEH · Special | Erbe Elektromedizin GmbH | 06/09/2026SE |
| K253230 | ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe…GEH · Traditional | Erbe Elektromedizin GmbH | 04/22/2026SE |
| K252198 | Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover)GEH · Traditional | Medical Brands Laboratories B.V. | 04/02/2026SE |
| K260377 | XSense Cryoablation System with CryoProbesGEH · Special | IceCure Medical , Ltd. | 02/24/2026SE |
| K251928 | CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console…GEH · Traditional | Medinice S.A. | 02/13/2026SE |
| K251524 | Dr. Yglo Skin Tag RemoverGEH · Traditional | Theotclab Healthcare B.V. | 01/12/2026SE |
| K250742 | Focused Cryotherapy SystemGEH · Traditional | Focused Cryo, Inc. | 12/09/2025SE |
| K253114 | TargetCool (RM-DT02W)GEH · Special | Recensmedical, Inc. | 10/16/2025SE |
More from Recensmedical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K200061 | HEATfx Microwave Ablation System, HEATfx Microwave Ablation System Cart, HEATfx 2.1…NEY · Traditional | 07/09/2020SE |
| K181741 | IceSphere 1.5 CX Cryoablation NeedleGEH · Special | 07/30/2018SE |
| K181153 | ICEfx Cryoablation SystemGEH · Special | 05/15/2018SE |
| K173037 | Visual-ICE MRI Cryoblation Console, Visual-ICE MRI Junction Box Assembly, Visual-ICE MRI…GEH · Traditional | 11/21/2017SE |
| K162599 | IcePearl 2.1 CX L, IceForce 2.1 CX LGEH · Special | 10/11/2016SE |
| K152133 | IcePearl 2.1 CX Cryoablation Needle, IcePearl 2.1 CX Prostate Cryoablation Kit…GEH · Special | 08/28/2015SE |
| K143564 | Visual-ICE Cryoablation System, Software Revision 1.3.1GEH · Special | 03/05/2015SE |
| K141485 | Icesphere 1.5 90 Cryoblation Needle, Iceshpere 1.5 Cyoblation NeedleGEH · Special | 07/02/2014SE |
| K140584 | Icerod CX Cryoablation NeedleGEH · Special | 03/31/2014SE |
| K123865 | Visual-Ice Cryoablation SystemGEH · Special | 02/06/2013SE |
Questions and answers
When was IcePearl 2.1 CX 90° Needle, IcePearl 2.1 CX L 90° Needle, IcePearl 2.1 CX Needle, IceFORCE 2.1 CX 90° Needle, IceFORCE 2.1 CX L 90° Needle, IceFORCE 2.1 CX Needle cleared by the FDA?
IcePearl 2.1 CX 90° Needle, IcePearl 2.1 CX L 90° Needle, IcePearl 2.1 CX Needle, IceFORCE 2.1 CX 90° Needle, IceFORCE 2.1 CX L 90° Needle, IceFORCE 2.1 CX Needle (K203032) received a 510(k) decision of Substantially Equivalent on November 2, 2020, 28 days after the submission was received.
What is the product code of K203032?
The FDA product code is GEH – Unit, Cryosurgical, Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4350.