510(k) · Cleared
ClearedVisual-ICE Cryoablation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corporation · GEH Unit, Cryosurgical, Accessories
Cleared on Aug 8, 2023 as substantially equivalent to K113860 (Galil Medical, Inc., 2012) and 2 other predicates after a 161-day review. Its family tree reaches back 9 generations to 2001. 4 later devices descend from it.
- Decided
- Aug 8, 2023
- Review
- 161 days
- Class
- Class II
- Product code
- GEH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K010991 (2001). 25 ancestors in all, the oldest K942299 (1995). 4 later devices descend from it, 3 citing it directly.
- Root · 9 generations backK010991 Seednet, Models FP6T5, FP5T5, FP5T3Galil Medical, Ltd. · 2001 · Recalled
- 5 generations between
- 3 generations backK113860 Visual-Ice Cryoablation SystemGalil Medical, Inc. · 2012 · Recalled
- 2 generations backK123865 Visual-Ice Cryoablation SystemGalil Medical, Inc. · 2013 · Recalled
- 1 generation backK143564 Visual-ICE Cryoablation System, Software Revision 1.3.1Galil Medical, Inc. · 2015 · Recalled
- This deviceK230551 Visual-ICE Cryoablation SystemBoston Scientific Corporation · 2023
- 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 ownK250742 Focused Cryotherapy SystemFocused Cryo, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK243245 IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1.5 CX…Boston Scientific Corp · 2024
- Descendant · cites it directly · 0 of its ownK234002 ICEfx Cryoablation System (FPRCH8000-02)Boston Scientific · 2024 · Recalled
Show all 9 generations
- Root · 9 generations backK010991 Seednet, Models FP6T5, FP5T5, FP5T3Galil Medical, Ltd. · 2001 · Recalled
- 8 generations backK011950 Seednet, Model FP6T5, FP5T5, FP5T3Galil Medical, Ltd. · 2002
- 7 generations backK021261 Seednet System and Seednetgold System, Models GP6T5, GP5T5, GP5T3…Galil Medical, Ltd. · 2002 · Recalled
- 6 generations backK031117 Seednet System and Seednetgold SystemGalil Medical, Ltd. · 2003
- 5 generations backK042667 Seednet Gold with Renal Kit, Model Fprpr 3021, (Renal Kit), Fprch…Galil Medical, Ltd. · 2004
- 4 generations backK060390 Seednet, Seednet Gold, Cryohit, Cryo TheraGalil Medical, Ltd. · 2006 · Recalled
- 3 generations backK113860 Visual-Ice Cryoablation SystemGalil Medical, Inc. · 2012 · Recalled
- 2 generations backK123865 Visual-Ice Cryoablation SystemGalil Medical, Inc. · 2013 · Recalled
- 1 generation backK143564 Visual-ICE Cryoablation System, Software Revision 1.3.1Galil Medical, Inc. · 2015 · Recalled
- This deviceK230551 Visual-ICE Cryoablation SystemBoston Scientific Corporation · 2023
Most influential descendants
Showing 4 of 4 · See all- K232635IceSeed 1.5 CX 90º Needle (H7493967433170); IceSeed 1.5 CX S 90º Needle (H7493967233100)Boston Scientific · 2023 · cites it directly1descendant
- K250742Focused Cryotherapy SystemFocused Cryo, Inc. · 2025 · cites it directly0descendants
- K243245IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1.5 CX Straight Needle…Boston Scientific Corp · 2024 · 2 generations on0descendants
- K234002ICEfx Cryoablation System (FPRCH8000-02)Boston Scientific · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K010991 | Seednet, Models FP6T5, FP5T5, FP5T3 | Galil Medical, Ltd. | 2001 | 2 |
| −8 | K011950 | Seednet, Model FP6T5, FP5T5, FP5T3 | Galil Medical, Ltd. | 2002 | — |
| −7 | K021261 | Seednet System and Seednetgold System, Models GP6T5, GP5T5, GP5T3, HP5T5 & HP5T3 | Galil Medical, Ltd. | 2002 | 1 |
| −6 | K031117 | Seednet System and Seednetgold System | Galil Medical, Ltd. | 2003 | — |
| −5 | K042667 | Seednet Gold with Renal Kit, Model Fprpr 3021, (Renal Kit), Fprch 2024… | Galil Medical, Ltd. | 2004 | — |
| −4 | K060390 | Seednet, Seednet Gold, Cryohit, Cryo Thera | Galil Medical, Ltd. | 2006 | 8 |
| −3 | K113860 | Visual-Ice Cryoablation System | Galil Medical, Inc. | 2012 | 2 |
| −2 | K123865 | Visual-Ice Cryoablation System | Galil Medical, Inc. | 2013 | 1 |
| −1 | K143564 | Visual-ICE Cryoablation System, Software Revision 1.3.1 | Galil Medical, Inc. | 2015 | 1 |
| 0 (this device) | K230551 | Visual-ICE Cryoablation System | Boston Scientific Corporation | 2023 | — |
| +1 | K232635 | IceSeed 1.5 CX 90º Needle (H7493967433170); IceSeed 1.5 CX S 90º Needle… | Boston Scientific | 2023 | 1 |
| +1 | K250742 | Focused Cryotherapy System | Focused Cryo, Inc. | 2025 | — |
| +2 | K243245 | IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1.5 CX Straight… | Boston Scientific Corp | 2024 | — |
| +1 | K234002 | ICEfx Cryoablation System (FPRCH8000-02) | Boston Scientific | 2024 | 2 |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K113860 | Visual-Ice Cryoablation SystemSummary page 5…osurgical unit and accessories Class: II Product Codes: GEH Primary Predicate: Visual-ICE™ Cryoablation System (K113860, K143564, K152133) Additional Predicate: N/A Indications For Use: The Visual-ICE™ Cryoablation System is intended… | 2012 |
| * | K143564 | Visual-ICE Cryoablation System, Software Revision 1.3.1Summary page 5…unit and accessories Class: II Product Codes: GEH Primary Predicate: Visual-ICE™ Cryoablation System (K113860, K143564, K152133) Additional Predicate: N/A Indications For Use: The Visual-ICE™ Cryoablation System is intended for cryo… | 2015 |
| * | K152133 | IcePearl 2.1 CX Cryoablation Needle, IcePearl 2.1 CX Prostate Cryoablation Kit…Summary page 5…accessories Class: II Product Codes: GEH Primary Predicate: Visual-ICE™ Cryoablation System (K113860, K143564, K152133) Additional Predicate: N/A Indications For Use: The Visual-ICE™ Cryoablation System is intended for cryoablative… | 2015 |
What descends from it? (4)
3 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)
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 22 years and passes through 3 companies; a new generation was cleared every 1.4 years on median.
- 14 of the 25 ancestors have a recall of any class.
- Of its descendants, K232635 (Boston Scientific, 2023) has gone furthest, with 1 descendant of its own.
- 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. 2023, 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 Visual-ICE™ Cryoablation System is intended for cryoablative destruction of tissue during surgical procedures. The Visual-ICE™ 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. The system is designed to destroy tissue by the application of extreme…
Read the full statement (265 words)
The Visual-ICE™ Cryoablation System is intended for cryoablative destruction of tissue during surgical procedures. The Visual-ICE™ 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. The system is designed to destroy tissue by the application of extreme cold temperatures including prostate and kidney tissue, liver metastases, tumors, and skin lesions.
The Visual-ICE 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/K230551 · printed Nov 5, 2026
Cite this page
510(k) Report. “K230551: Visual-ICE Cryoablation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K230551
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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