510(k) · Cleared
ClearedXSense Cryoablation System with CryoProbes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
IceCure Medical, Ltd. · GEH Unit, Cryosurgical, Accessories
Cleared on Feb 24, 2026 as substantially equivalent to K240892 (IceCure Medical, Ltd., 2024) after a 19-day review. Its family tree reaches back 10 generations to 2001.
- Decided
- Feb 24, 2026
- Review
- 19 days
- Class
- Class II
- Product code
- GEH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K003811 (2001). 22 ancestors in all, the oldest K790187 (1979). No later device cites it as a predicate yet.
- Root · 10 generations backK003811 Cryocare Surgical SystemEndocare, Inc. · 2001
- 6 generations between
- 3 generations backK102360 Icesence 3IceCure Medical, Ltd. · 2010 · Recalled
- 2 generations backK183213 IceSense 3, ProSense, MultiSenseIceCure Medical, Ltd. · 2019
- 1 generation backK240892 XSense Cryoablation System with CryoprobesIceCure Medical, Ltd. · 2024
- This deviceK260377 XSense Cryoablation System with CryoProbesIceCure Medical, Ltd. · 2026
Show all 10 generations
- Root · 10 generations backK003811 Cryocare Surgical SystemEndocare, Inc. · 2001
- 9 generations backK020605 Sanarus Visica Treatment SystemSanarus Medical, Inc. · 2002
- 8 generations backK021211 Modification to Sanarus Visica Treatment SystemSanarus Medical, Inc. · 2002
- 7 generations backK022314 Sanarus Visica Treatment SystemSanarus Medical, Inc. · 2002 · Recalled
- 6 generations backK052861 Modification to:Sanarus Visica Treatment System , Models VS2000Sanarus Medical, Inc. · 2005
- 5 generations backK061510 Sanarus Visica Treatment SystemSanarus Medical, Inc. · 2006
- 4 generations backK062896 V2 Treatment System (V2 Console, V2 Ice Probe, V2 Dewars) Models…Sanarus Medical, Inc. · 2007
- 3 generations backK102360 Icesence 3IceCure Medical, Ltd. · 2010 · Recalled
- 2 generations backK183213 IceSense 3, ProSense, MultiSenseIceCure Medical, Ltd. · 2019
- 1 generation backK240892 XSense Cryoablation System with CryoprobesIceCure Medical, Ltd. · 2024
- This deviceK260377 XSense Cryoablation System with CryoProbesIceCure Medical, Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K003811 | Cryocare Surgical System | Endocare, Inc. | 2001 | — |
| −9 | K020605 | Sanarus Visica Treatment System | Sanarus Medical, Inc. | 2002 | — |
| −8 | K021211 | Modification to Sanarus Visica Treatment System | Sanarus Medical, Inc. | 2002 | — |
| −7 | K022314 | Sanarus Visica Treatment System | Sanarus Medical, Inc. | 2002 | 1 |
| −6 | K052861 | Modification to:Sanarus Visica Treatment System , Models VS2000 | Sanarus Medical, Inc. | 2005 | — |
| −5 | K061510 | Sanarus Visica Treatment System | Sanarus Medical, Inc. | 2006 | — |
| −4 | K062896 | V2 Treatment System (V2 Console, V2 Ice Probe, V2 Dewars) Models; VS3000… | Sanarus Medical, Inc. | 2007 | — |
| −3 | K102360 | Icesence 3 | IceCure Medical, Ltd. | 2010 | 1 |
| −2 | K183213 | IceSense 3, ProSense, MultiSense | IceCure Medical, Ltd. | 2019 | — |
| −1 | K240892 | XSense Cryoablation System with Cryoprobes | IceCure Medical, Ltd. | 2024 | — |
| 0 (this device) | K260377 | XSense Cryoablation System with CryoProbes | IceCure Medical, Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1984 | 1 | 0 |
| 1990 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 4 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 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 |
|---|---|---|---|
| * | K240892 | XSense Cryoablation System with CryoprobesSummary page 5…GEH Classification: Class II Medical Device Review Panel: General and Plastic Surgery Predicate Device: XSense Cryoablation System with CryoProbes (K240892) Intended Use/Indication for Use: XSense Cryoablation System with CryoProbes is intended for cryogenic destruction of tissue… | 2024 |
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 25 years and passes through 3 companies; a new generation was cleared every 1.7 years on median.
- 2 of the 22 ancestors have a recall of any class.
- 1 other device also cites its predicate K240892.
How does its category compare?
All GEH devicesGEH Unit, Cryosurgical, Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?
XSense Cryoablation System with CryoProbes is intended for cryogenic destruction of tissue during surgical procedures by the application of extreme cold temperatures. XSense Cryoablation System with CryoProbes 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. The system is designed to destroy tissue by the…
Read the full statement (295 words)
XSense Cryoablation System with CryoProbes is intended for cryogenic destruction of tissue during surgical procedures by the application of extreme cold temperatures.
XSense Cryoablation System with CryoProbes 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.
The system is designed to destroy tissue by the application of extreme cold temperatures including fibroadenomas, prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts.
XSense Cryoablation System with CryoProbes may be used with an imaging device such as an ultrasound to provide real-time visualization of the cryosurgical procedure.
The system has the following specific indications:
Urology: Ablate prostate tissue in cases of prostate cancer and benign prostatic 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. Palliation of tumors of the skin. Destruction of warts or lesions.
Gynecology: Ablation of malignant neoplasia or benign dysplasia of the female genitalia.
ENT (Ear, Nose, and Throat): Palliation of tumors of the oral cavity and ablation of leukoplakia of the mouth.
General Surgery: Ablation of breast fibroadenomas, leukoplakia of mouth, 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, hemorrhoids, anal fissures, perianal condylomata, pilonidal cysts actinic and seborrheic keratoses, cavernous hemangiomas, recurrent cancerous lesions. Palliation of tumors of the rectum, hemorrhoids, anal fissures, pilonidal cysts, and recurrent cancerous lesions. Destruction of warts or lesions. Palliation of tumors of the oral cavity, rectum, and skin.
Thoracic Surgery: Ablation of arrhythmic cardiac tissue and cancerous lesions.
Proctology: Ablation of benign or malignant growths of the anus and rectum and hemorrhoids.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260377 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260377: XSense Cryoablation System with CryoProbes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260377
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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