510(k) · Cleared
Recalled · Class II · 2019Visual-ICE Cryoablation System, Software Revision 1.3.1
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 Mar 5, 2015 as substantially equivalent to K113860 (Galil Medical, Inc., 2012) and 2 other predicates after a 79-day review. Its family tree reaches back 8 generations to 2001. 10 later devices descend from it. It has been recalled once.
- Decided
- Mar 5, 2015
- Review
- 79 days
- Class
- Class II
- Product code
- GEH
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 8 generations to K010991 (2001). 19 ancestors in all, the oldest K980913 (1998). 10 later devices descend from it, 3 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 backK113860 Visual-Ice Cryoablation SystemGalil Medical, Inc. · 2012 · Recalled
- 1 generation backK123865 Visual-Ice Cryoablation SystemGalil Medical, Inc. · 2013 · Recalled
- This deviceK143564 Visual-ICE Cryoablation System, Software Revision 1.3.1Galil Medical, Inc. · 2015
- Descendant · cites it directly · 5 of its ownK153489 Cryocare CS Surgical SystemHealthtronics · 2016
- Descendant · cites it directly · 4 of its ownK230551 Visual-ICE Cryoablation SystemBoston Scientific Corporation · 2023
- Descendant · 2 generations on · 4 of its ownK201588 CRYOCARE TOUCH System and Accessories, Endocare 1.7mm Round Ice…Varian Medical Systems, Inc. · 2020
- Descendant · 2 generations on · 1 of its ownK232635 IceSeed 1.5 CX 90º Needle (H7493967433170); IceSeed 1.5 CX S 90º…Boston Scientific · 2023 · Recalled
- Descendant · 3 generations on · 1 of its ownK230271 ISOLIS CryoprobeVarian Medical Systems, Inc. · 2023
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K153489Cryocare CS Surgical SystemHealthtronics · 2016 · cites it directly5descendants
- K230551Visual-ICE Cryoablation SystemBoston Scientific Corporation · 2023 · cites it directly4descendants
- K201588CRYOCARE TOUCH System and Accessories, Endocare 1.7mm Round Ice PerCryo Cryoprobe…Varian Medical Systems, Inc. · 2020 · 2 generations on4descendants
- K232635IceSeed 1.5 CX 90º Needle (H7493967433170); IceSeed 1.5 CX S 90º Needle (H7493967233100)Boston Scientific · 2023 · 2 generations on1descendant
- K230271ISOLIS CryoprobeVarian Medical Systems, Inc. · 2023 · 3 generations on1descendant
View 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 | K113860 | Visual-Ice Cryoablation System | Galil Medical, Inc. | 2012 | 2 |
| −1 | K123865 | Visual-Ice Cryoablation System | Galil Medical, Inc. | 2013 | 1 |
| 0 (this device) | K143564 | Visual-ICE Cryoablation System, Software Revision 1.3.1 | Galil Medical, Inc. | 2015 | — |
| +1 | K153489 | Cryocare CS Surgical System | Healthtronics | 2016 | — |
| +1 | K230551 | Visual-ICE Cryoablation System | Boston Scientific Corporation | 2023 | — |
| +2 | K201588 | CRYOCARE TOUCH System and Accessories, Endocare 1.7mm Round Ice PerCryo… | Varian Medical Systems, Inc. | 2020 | — |
| +2 | K232635 | IceSeed 1.5 CX 90º Needle (H7493967433170); IceSeed 1.5 CX S 90º Needle… | Boston Scientific | 2023 | 1 |
| +3 | K230271 | ISOLIS Cryoprobe | Varian Medical Systems, Inc. | 2023 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 4 | 0 |
| 2024 | 2 | 0 |
| 2025 | 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? (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 4…Cryosurgical unit and accessories (GEH) Name: 21 CFR 878.4350 Predicate Device: Visual-ICE® Cryoablation System (K113860) Visual-ICE® Cryoablation System, Software Revision 1.2.2… | 2012 |
| * | K123865 | Visual-Ice Cryoablation SystemSummary page 4…sual-ICE® Cryoablation System (K113860) Visual-ICE® Cryoablation System, Software Revision 1.2.2 (K123865) IceRod CX Cryoablation Needle (K121251) Date of Preparation: March 3, 2015… | 2013 |
| * | K121251 | Icerod CX Cryoablation Needle Icerod CX Cryoablation Needle MultipackSummary page 4…Visual-ICE® Cryoablation System, Software Revision 1.2.2 (K123865) IceRod CX Cryoablation Needle (K121251) Date of Preparation: March 3, 2015 Device Description: The Visual-ICE Cryoablation System is a mobile console s… | 2012 |
What descends from it? (10)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 25, 2019 | Class II | Z-0404-2020 | Environmental control | Visual-ICE utilizing the IceSeed 1.5 and IceRod 1.5 PLUS cryoablation needles could have issues with the needle clogging and/or inadequate freezing performance. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 2 companies; a new generation was cleared every 1.4 years on median.
- 11 of the 19 ancestors have a recall of any class.
- Of its descendants, K153489 (Healthtronics, 2016) has gone furthest, with 5 descendants 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. 2015, 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 indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery, 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 Visual-ICE Cryoablation System has the following…
Read the full statement (226 words)
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, 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 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
• 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, hemorrhoids, 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: Ablation of arrhythmic cardiac tissue cancerous lesions
• Proctology: Ablation of benign or malignant growths of the anus or rectum, and hemorrhoids
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143564 · printed Nov 5, 2026
Cite this page
510(k) Report. “K143564: Visual-ICE Cryoablation System, Software Revision 1.3.1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K143564
Report an extraction error
Are you the manufacturer?
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