510(k) · Cleared
Recalled · Class II · 2020IceSphere 1.5 CX Cryoablation Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Galil Medical, Ltd. · GEH Unit, Cryosurgical, Accessories
Cleared on Jul 30, 2018 as substantially equivalent to K141485 (Galil Medical, Ltd., 2014) and 2 other predicates after a 28-day review. Its family tree reaches back 8 generations to 2001. 2 later devices descend from it. It has been recalled once.
- Decided
- Jul 30, 2018
- Review
- 28 days
- Class
- Class II
- Product code
- GEH
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 8 generations to K010991 (2001). 20 ancestors in all, the oldest K980913 (1998). 2 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK010991 Seednet, Models FP6T5, FP5T5, FP5T3Galil Medical, Ltd. · 2001 · Recalled
- 7 generations backK011950 Seednet, Model FP6T5, FP5T5, FP5T3Galil Medical, Ltd. · 2002
- 6 generations backK021261 Seednet System and Seednetgold System, Models GP6T5, GP5T5, GP5T3…Galil Medical, Ltd. · 2002 · Recalled
- 5 generations backK031117 Seednet System and Seednetgold SystemGalil Medical, Ltd. · 2003
- 4 generations backK042667 Seednet Gold with Renal Kit, Model Fprpr 3021, (Renal Kit), Fprch…Galil Medical, Ltd. · 2004
- 3 generations backK060390 Seednet, Seednet Gold, Cryohit, Cryo TheraGalil Medical, Ltd. · 2006 · Recalled
- 2 generations backK121251 Icerod CX Cryoablation Needle Icerod CX Cryoablation Needle MultipackGalil Medical, Ltd. · 2012 · Recalled
- 1 generation backK140584 Icerod CX Cryoablation NeedleGalil Medical, Ltd. · 2014
- This deviceK181741 IceSphere 1.5 CX Cryoablation NeedleGalil Medical, Ltd. · 2018
- Descendant · cites it directly · 1 of its ownK232635 IceSeed 1.5 CX 90º Needle (H7493967433170); IceSeed 1.5 CX S 90º…Boston Scientific · 2023 · Recalled
- Descendant · cites it directly · 0 of its ownK243245 IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1.5 CX…Boston Scientific Corp · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K010991 | Seednet, Models FP6T5, FP5T5, FP5T3 | Galil Medical, Ltd. | 2001 | 2 |
| −7 | K011950 | Seednet, Model FP6T5, FP5T5, FP5T3 | Galil Medical, Ltd. | 2002 | — |
| −6 | K021261 | Seednet System and Seednetgold System, Models GP6T5, GP5T5, GP5T3, HP5T5 & HP5T3 | Galil Medical, Ltd. | 2002 | 1 |
| −5 | K031117 | Seednet System and Seednetgold System | Galil Medical, Ltd. | 2003 | — |
| −4 | K042667 | Seednet Gold with Renal Kit, Model Fprpr 3021, (Renal Kit), Fprch 2024… | Galil Medical, Ltd. | 2004 | — |
| −3 | K060390 | Seednet, Seednet Gold, Cryohit, Cryo Thera | Galil Medical, Ltd. | 2006 | 8 |
| −2 | K121251 | Icerod CX Cryoablation Needle Icerod CX Cryoablation Needle Multipack | Galil Medical, Ltd. | 2012 | 1 |
| −1 | K140584 | Icerod CX Cryoablation Needle | Galil Medical, Ltd. | 2014 | — |
| 0 (this device) | K181741 | IceSphere 1.5 CX Cryoablation Needle | Galil Medical, Ltd. | 2018 | — |
| +1 | K232635 | IceSeed 1.5 CX 90º Needle (H7493967433170); IceSeed 1.5 CX S 90º Needle… | Boston Scientific | 2023 | 1 |
| +1 | K243245 | IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1.5 CX Straight… | Boston Scientific Corp | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GEH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GEH device
- #1 K211099 Freeze’n Clear Skin Clinic Warts & Tagsscore 25.4 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K141485 | Icesphere 1.5 90 Cryoblation Needle, Iceshpere 1.5 Cyoblation NeedleSummary page 4…egulation Number: 21 CFR 878.4350 Product Code: GEH Predicate Device 510(k): IceSphere 1.5 90° Cryoablation Needle (K141485) IceRod 1.5 CX 90° Cryoablation Needle (K121251 &… | 2014 |
| * | K121251 | Icerod CX Cryoablation Needle Icerod CX Cryoablation Needle MultipackSummary page 4…dicate Device 510(k): IceSphere 1.5 90° Cryoablation Needle (K141485) IceRod 1.5 CX 90° Cryoablation Needle (K121251 & K140584) Date of Preparation: June 28, 2018 Device Descript… | 2012 |
| * | K140584 | Icerod CX Cryoablation NeedleSummary page 4…0° Cryoablation Needle (K141485) IceRod 1.5 CX 90° Cryoablation Needle (K121251 & K140584) Date of Preparation: June 28, 2018 Device Description: Galil Medical’s IceSphere 1.5 CX Cryoablation Ne… | 2014 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 18, 2020 | Class II | Z-0664-2021 | Under Investigation by firm | Complaint trend regarding needle shaft gas leaks. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 1 company; a new generation was cleared every 1.5 years on median.
- 11 of the 20 ancestors have a recall of any class.
- Of its descendants, K232635 (Boston Scientific, 2023) has gone furthest, with 1 descendant of its own.
How does its category compare?
All GEH devicesGEH Unit, Cryosurgical, Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · GEH
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEH
77in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEH
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GEH
171in 2025
MAUDE reports naming product code GEH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 6 | 71 | 3 | 23 |
| 2008 | 1 | — | 2 | 29 |
| 2009 | 4 | 121 | 13 | 21 |
| 2010 | 4 | 86 | 4 | 173 |
| 2011 | 7 | 91 | 0 | 61 |
| 2012 | 4 | 96 | 3 | 91 |
| 2013 | 4 | 76 | 0 | 91 |
| 2014 | 6 | 42 | 2 | 57 |
| 2015 | 11 | 72 | 0 | 97 |
| 2016 | 15 | 60 | 0 | 143 |
| 2017 | 12 | 83 | 0 | 216 |
| 2018 | 6 | 42 | 1 | 208 |
| 2019 | 6 | 115 | 1 | 455 |
| 2020 | 8 | 113 | 37 | 277 |
| 2021 | 6 | 206 | 0 | 213 |
| 2022 | 6 | 56 | 0 | 230 |
| 2023 | 8 | 136 | 2 | 164 |
| 2024 | 9 | 85 | 0 | 141 |
| 2025 | 10 | 77 | 0 | 171 |
| 2026 | 8 | 148 | 2 | — |
What is it indicated for?
The Galil Medical 1.5 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures. The 1.5 CX Cryoablation Needles, when used with a Galil Medical Cryoablation System, are designed to destroy tissue by the application of extremely cold temperatures. A full list of specific indications can be found in the respective Galil Medical Cryoablation System User Manual. For reference, the indications for use from the…
Read the full statement (307 words)
The Galil Medical 1.5 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures. The 1.5 CX Cryoablation Needles, when used with a Galil Medical Cryoablation System, are designed to destroy tissue by the application of extremely cold temperatures. A full list of specific indications can be found in the respective Galil Medical Cryoablation System User Manual.
For reference, the indications for use from the Galil Medical Cryoablation Systems User Manuals are provided below.
The Galil Medical Cryoablation Systems 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 (including prostate and kidney tissue, liver metastases, tumors, skin lesions) by the application of extremely cold temperatures. The Galil Medical Cryoablation Systems 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 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 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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181741 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181741: IceSphere 1.5 CX Cryoablation Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181741
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026