510(k) · Cleared
Recalled · Class II · 2025ICEfx Cryoablation System (FPRCH8000-02)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific · GEH Unit, Cryosurgical, Accessories
Cleared on Mar 13, 2024 as substantially equivalent to K230551 (Boston Scientific Corporation, 2023) after an 85-day review. Its family tree reaches back 10 generations to 2001. It has been recalled 2 times.
- Decided
- Mar 13, 2024
- Review
- 85 days
- Class
- Class II
- Product code
- GEH
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 10 generations to K010991 (2001). 26 ancestors in all, the oldest K942299 (1995). No later device cites it as a predicate yet.
- Root · 10 generations backK010991 Seednet, Models FP6T5, FP5T5, FP5T3Galil Medical, Ltd. · 2001 · Recalled
- 6 generations between
- 3 generations backK123865 Visual-Ice Cryoablation SystemGalil Medical, Inc. · 2013 · Recalled
- 2 generations backK143564 Visual-ICE Cryoablation System, Software Revision 1.3.1Galil Medical, Inc. · 2015 · Recalled
- 1 generation backK230551 Visual-ICE Cryoablation SystemBoston Scientific Corporation · 2023
- This deviceK234002 ICEfx Cryoablation System (FPRCH8000-02)Boston Scientific · 2024
Show all 10 generations
- Root · 10 generations backK010991 Seednet, Models FP6T5, FP5T5, FP5T3Galil Medical, Ltd. · 2001 · Recalled
- 9 generations backK011950 Seednet, Model FP6T5, FP5T5, FP5T3Galil Medical, Ltd. · 2002
- 8 generations backK021261 Seednet System and Seednetgold System, Models GP6T5, GP5T5, GP5T3…Galil Medical, Ltd. · 2002 · Recalled
- 7 generations backK031117 Seednet System and Seednetgold SystemGalil Medical, Ltd. · 2003
- 6 generations backK042667 Seednet Gold with Renal Kit, Model Fprpr 3021, (Renal Kit), Fprch…Galil Medical, Ltd. · 2004
- 5 generations backK060390 Seednet, Seednet Gold, Cryohit, Cryo TheraGalil Medical, Ltd. · 2006 · Recalled
- 4 generations backK113860 Visual-Ice Cryoablation SystemGalil Medical, Inc. · 2012 · Recalled
- 3 generations backK123865 Visual-Ice Cryoablation SystemGalil Medical, Inc. · 2013 · Recalled
- 2 generations backK143564 Visual-ICE Cryoablation System, Software Revision 1.3.1Galil Medical, Inc. · 2015 · Recalled
- 1 generation backK230551 Visual-ICE Cryoablation SystemBoston Scientific Corporation · 2023
- This deviceK234002 ICEfx Cryoablation System (FPRCH8000-02)Boston Scientific · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K010991 | Seednet, Models FP6T5, FP5T5, FP5T3 | Galil Medical, Ltd. | 2001 | 2 |
| −9 | K011950 | Seednet, Model FP6T5, FP5T5, FP5T3 | Galil Medical, Ltd. | 2002 | — |
| −8 | K021261 | Seednet System and Seednetgold System, Models GP6T5, GP5T5, GP5T3, HP5T5 & HP5T3 | Galil Medical, Ltd. | 2002 | 1 |
| −7 | K031117 | Seednet System and Seednetgold System | Galil Medical, Ltd. | 2003 | — |
| −6 | K042667 | Seednet Gold with Renal Kit, Model Fprpr 3021, (Renal Kit), Fprch 2024… | Galil Medical, Ltd. | 2004 | — |
| −5 | K060390 | Seednet, Seednet Gold, Cryohit, Cryo Thera | Galil Medical, Ltd. | 2006 | 8 |
| −4 | K113860 | Visual-Ice Cryoablation System | Galil Medical, Inc. | 2012 | 2 |
| −3 | K123865 | Visual-Ice Cryoablation System | Galil Medical, Inc. | 2013 | 1 |
| −2 | K143564 | Visual-ICE Cryoablation System, Software Revision 1.3.1 | Galil Medical, Inc. | 2015 | 1 |
| −1 | K230551 | Visual-ICE Cryoablation System | Boston Scientific Corporation | 2023 | — |
| 0 (this device) | K234002 | ICEfx Cryoablation System (FPRCH8000-02) | Boston Scientific | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 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? (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 |
|---|---|---|---|
| * | K230551 | Visual-ICE Cryoablation SystemSummary page 5…poration Page 2 of 3 Primary Predicate: Visual-ICE™ Cryoablation System (K230551) Additional Predicate: N/A Device Description: The ICEfx Cryoablation System is a mobile system intended for cryoablat… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 18, 2025 | Class II | Z-2551-2025 | Process control | Certain desiccant tube subassemblies were built with end caps that were not correctly tightened. |
| Aug 18, 2025 | Class II | Z-2550-2025 | Process control | Certain desiccant tube subassemblies were built with end caps that were not correctly tightened. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 4 companies; a new generation was cleared every 1.4 years on median.
- 14 of the 26 ancestors have a recall of any class.
- 2 other devices also cite its predicate K230551.
How does its category compare?
All GEH devicesGEH Unit, Cryosurgical, Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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, and skin lesions) by the application of extremely cold temperatures. The ICEfx…
Read the full statement (258 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, and 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. 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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K234002 · printed Nov 4, 2026
Cite this page
510(k) Report. “K234002: ICEfx Cryoablation System (FPRCH8000-02).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K234002
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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