# K243245: IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1.5 CX Straight Needle (H7493968435730); IceRod 1.5 CX Straight Needle (H7493968535330)

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corp
- Decided: Oct 18, 2024 after 7 days
- Product code: GEH (Unit, Cryosurgical, Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K010991 (2001). 29 ancestors in all.
No later device cites it as a predicate yet.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232635: IceSeed 1.5 CX 90º Needle (H7493967433170); IceSeed 1.5 CX S 90º Needle (H7493967233100), Boston Scientific (2023) Summary page 6.
- K181741: IceSphere 1.5 CX Cryoablation Needle, Galil Medical, Ltd. (2018) Summary page 6.
- K140584: Icerod CX Cryoablation Needle, Galil Medical, Ltd. (2014) Summary page 6.

## Indications for use
The Boston Scientific disposable IceRod Cryoablation Needle, IceSphere Cryoablation Needle, IceSeed Cryoablation Needle, IcePearl Cryoablation Needle, and IceForce Cryoablation Needle (CX Needles) are meant to be connected to a Boston Scientific ICEfx Cryoablation System or Visual-ICE Cryoablation System when performing cryoablative tissue destruction through application of extremely cold temperatures. The needles are intended to convert high-pressure gas to either a very cold Freezing application or to a warm Thawing application. The Boston Scientific CX Needles, when used with ICEfx Cryoablation System or Visual-ICE Cryoablation System, 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 CX Needles are designed to destroy tissue (including prostate and kidney tissue, liver metastases, tumors, and skin lesions) by the application of extremely cold temperatures. The CX 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. Palliation of pain associated with metastatic lesions involving bone in patients who have failed or are not candidates for standard radiation therapy. • 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 hemangiomas, mucocele cysts, multiple warts, plantar warts, actinic and seborrheic keratosis, cavernous hemangiomas, peri-anal 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, anal fissures, pilonidal cysts, and recurrent cancerous lesions, ablation of breast fibroadenomas • 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

Source page: https://510kreport.com/device/K243245
Methodology: https://510kreport.com/methodology