# K152133: IcePearl 2.1 CX Cryoablation Needle, IcePearl 2.1 CX Prostate Cryoablation Kit Visual-ICE System, IceFORCE 2.1 CX Cryoablation Needle, IceFORCE 2.1 CX Prostate Cryoablation Kit Visual-ICE System

- Pathway: 510(k) (Special)
- Applicant: Galil Medical, Ltd.
- Decided: Aug 28, 2015 after 28 days
- Product code: GEH (Unit, Cryosurgical, Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4350
- Recalls of this device: 18 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K010991 (2001). 21 ancestors in all.
13 later devices descend from it; 4 cite it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121251: Icerod CX Cryoablation Needle Icerod CX Cryoablation Needle Multipack, Galil Medical, Ltd. (2012) Summary page 4.
- K140584: Icerod CX Cryoablation Needle, Galil Medical, Ltd. (2014) Summary page 4.
- K111859: Iceedge 2.4 Cryoablation Needle,Iceedge 2.4 Cryoablation Needle Multipack, Galil Medical, Inc. (2011) Summary page 4.

## Most influential descendants
- K161480: R2 Dermal Cooling System (2016), 5 descendants of its own
- K230551: Visual-ICE Cryoablation System (2023), 4 descendants of its own
- K171398: Dermal Cooling System (2017), 4 descendants of its own
- K201260: Dermal Cooling System (2020), 3 descendants of its own
- K203006: R2 Dermabrasion Tip (for Dermal Cooling System) (2021), 2 descendants of its own

## Recalls of this device
- Nov 18, 2020 · Class II · Z-0660-2021: Complaint trend regarding needle shaft gas leaks.
- Nov 18, 2020 · Class II · Z-0661-2021: Complaint trend regarding needle shaft gas leaks.
- Nov 18, 2020 · Class II · Z-0682-2021: Complaint trend regarding needle shaft gas leaks.
- Nov 18, 2020 · Class II · Z-0657-2021: Complaint trend regarding needle shaft gas leaks.
- Nov 18, 2020 · Class II · Z-0658-2021: Complaint trend regarding needle shaft gas leaks.
- Nov 18, 2020 · Class II · Z-0685-2021: Complaint trend regarding needle shaft gas leaks.
- Nov 18, 2020 · Class II · Z-0683-2021: Complaint trend regarding needle shaft gas leaks.
- Nov 18, 2020 · Class II · Z-0684-2021: Complaint trend regarding needle shaft gas leaks.
- Jun 4, 2020 · Class II · Z-2683-2020: The needle surface deteriorated due to unexpected electrolysis during procedure.
- Jun 4, 2020 · Class II · Z-2678-2020: The needle surface deteriorated due to unexpected electrolysis during procedure.
- Jun 4, 2020 · Class II · Z-2681-2020: The needle surface deteriorated due to unexpected electrolysis during procedure.
- Jun 4, 2020 · Class II · Z-2679-2020: The needle surface deteriorated due to unexpected electrolysis during procedure.
- Jun 4, 2020 · Class II · Z-2682-2020: The needle surface deteriorated due to unexpected electrolysis during procedure.
- Jun 4, 2020 · Class II · Z-2680-2020: The needle surface deteriorated due to unexpected electrolysis during procedure.
- Jun 4, 2020 · Class II · Z-2676-2020: The needle surface deteriorated due to unexpected electrolysis during procedure.
- Jun 4, 2020 · Class II · Z-2677-2020: The needle surface deteriorated due to unexpected electrolysis during procedure.
- Jun 4, 2020 · Class II · Z-2675-2020: The needle surface deteriorated due to unexpected electrolysis during procedure.
- Jun 4, 2020 · Class II · Z-2674-2020: The needle surface deteriorated due to unexpected electrolysis during procedure.

## Indications for use
Galil Medical’s IcePearl 2.1 CX and IceFORCE 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures. The IcePearl 2.1 CX and IceFORCE 2.1 CX Cryoablation Needles are indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery (with the exception of cardiac tissue), ENT, gynecology, oncology, proctology, and urology. The systems are designed to destroy tissue by the application of extreme cold temperatures including prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts. The Galil Medical IcePearl 2.1 CX and IceFORCE 2.1 CX Cryoablation Needles have the following specific indications: • Urology (ablation of prostate tissue in cases of prostate cancer and Benign Prostate Hyperplasia "BPH") • Oncology (ablation of cancerous or malignant tissue and benign tumors, and palliative intervention) • Dermatology (ablation or freezing of skin cancers and other cutaneous disorders. Destruction of warts or lesions, angiomas, sebaceous hyperplasia, basal cell tumors of the eyelid or canthus area, ulcerated basal cell tumors, dermatofibromas small hemanglomas, mucocele cysts, multiple warts, plantar warts, actinic and seborrheic keratoses, cavernous hemanglomas, perianal condylomata, and palliation of tumors of the skin.) • Gynecology (ablation of malignant neoplasia or benign dysplasia of the female genitalia) • General surgery (palliation of tumors of the rectum, hemorrhoids, anal fissures, pilonidal cysts, and recurrent cancerous lesions, ablation of breast fibroadenoma) • ENT (Palliation of tumors of the oral cavity and ablation of leukoplakia of the mouth) • Thoracic surgery (with the exception of cardiac tissue) • Proctology (ablation of benign or malignant growths of the anus or rectum, and hemorrhoids)

Source page: https://510kreport.com/device/K152133
Methodology: https://510kreport.com/methodology