510(k) · Cleared
ClearedICEfx Cryoablation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Galil Medical, Inc. · GEH Unit, Cryosurgical, Accessories
Cleared on May 15, 2018 as substantially equivalent to K113860 (Galil Medical, Inc., 2012) after a 14-day review. Its family tree reaches back 7 generations to 2001.
- Decided
- May 15, 2018
- Review
- 14 days
- Class
- Class II
- Product code
- GEH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K010991 (2001). 15 ancestors in all, the oldest K980913 (1998). No later device cites it as a predicate yet.
- Root · 7 generations backK010991 Seednet, Models FP6T5, FP5T5, FP5T3Galil Medical, Ltd. · 2001 · Recalled
- 6 generations backK011950 Seednet, Model FP6T5, FP5T5, FP5T3Galil Medical, Ltd. · 2002
- 5 generations backK021261 Seednet System and Seednetgold System, Models GP6T5, GP5T5, GP5T3…Galil Medical, Ltd. · 2002 · Recalled
- 4 generations backK031117 Seednet System and Seednetgold SystemGalil Medical, Ltd. · 2003
- 3 generations backK042667 Seednet Gold with Renal Kit, Model Fprpr 3021, (Renal Kit), Fprch…Galil Medical, Ltd. · 2004
- 2 generations backK060390 Seednet, Seednet Gold, Cryohit, Cryo TheraGalil Medical, Ltd. · 2006 · Recalled
- 1 generation backK113860 Visual-Ice Cryoablation SystemGalil Medical, Inc. · 2012 · Recalled
- This deviceK181153 ICEfx Cryoablation SystemGalil Medical, Inc. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K010991 | Seednet, Models FP6T5, FP5T5, FP5T3 | Galil Medical, Ltd. | 2001 | 2 |
| −6 | K011950 | Seednet, Model FP6T5, FP5T5, FP5T3 | Galil Medical, Ltd. | 2002 | — |
| −5 | K021261 | Seednet System and Seednetgold System, Models GP6T5, GP5T5, GP5T3, HP5T5 & HP5T3 | Galil Medical, Ltd. | 2002 | 1 |
| −4 | K031117 | Seednet System and Seednetgold System | Galil Medical, Ltd. | 2003 | — |
| −3 | K042667 | Seednet Gold with Renal Kit, Model Fprpr 3021, (Renal Kit), Fprch 2024… | Galil Medical, Ltd. | 2004 | — |
| −2 | K060390 | Seednet, Seednet Gold, Cryohit, Cryo Thera | Galil Medical, Ltd. | 2006 | 8 |
| −1 | K113860 | Visual-Ice Cryoablation System | Galil Medical, Inc. | 2012 | 2 |
| 0 (this device) | K181153 | ICEfx Cryoablation System | Galil Medical, Inc. | 2018 | — |
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 |
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? (1)
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 |
|---|---|---|---|
| * | K113860 | Visual-Ice Cryoablation SystemSummary page 4…Regulation Number: 21 CFR 878.4350 Product Code: GEH Predicate Device 510(k): Visual-ICE Cryoablation System (K113860) Date of Preparation: April 30, 2018 Device Description: The ICEfx™ Cryoablation System is a mobile system int… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 2 companies; a new generation was cleared every 1.4 years on median.
- 7 of the 15 ancestors have a recall of any class.
- 4 other devices also cite its predicate K113860.
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 ICEfx Cryoablation System is 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. This System is designed to destroy tissue (including prostate and kidney tissue, liver metastases, tumors, skin lesions) by the application of extremely cold temperatures. The ICEfx…
Read the full statement (228 words)
The ICEfx Cryoablation System is 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. This System is designed to destroy tissue (including prostate and kidney tissue, liver metastases,
tumors, skin lesions) by the application of extremely cold temperatures.
The ICEfx Cryoablation System has 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 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
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K181153 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181153: ICEfx Cryoablation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181153
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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