510(k) · Cleared
Recalled · Class II · 2020IcePearl 2.1 CX Cryoablation Needle, IcePearl 2.1 CX Prostate Cryoablation Kit Visual-ICE System, IceFORCE 2.1 CX Cryoablation Needle, IceFORCE 2.1 CX Prostate Cryoablation Kit Visual-ICE System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Galil Medical, Ltd. · GEH Unit, Cryosurgical, Accessories
Cleared on Aug 28, 2015 as substantially equivalent to K121251 (Galil Medical, Ltd., 2012) and 2 other predicates after a 28-day review. Its family tree reaches back 8 generations to 2001. 13 later devices descend from it. It has been recalled 18 times.
- Decided
- Aug 28, 2015
- Review
- 28 days
- Class
- Class II
- Product code
- GEH
- Recalls
- 18
- Predicates
- 3
Its longest line of descent runs back 8 generations to K010991 (2001). 21 ancestors in all, the oldest K942299 (1995). 13 later devices descend from it, 4 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 backK121251 Icerod CX Cryoablation Needle Icerod CX Cryoablation Needle MultipackGalil Medical, Ltd. · 2012 · Recalled
- 1 generation backK140584 Icerod CX Cryoablation NeedleGalil Medical, Ltd. · 2014
- This deviceK152133 IcePearl 2.1 CX Cryoablation Needle, IcePearl 2.1 CX Prostate…Galil Medical, Ltd. · 2015
- Descendant · cites it directly · 5 of its ownK161480 R2 Dermal Cooling SystemR2 Dermatology · 2016
- Descendant · cites it directly · 4 of its ownK230551 Visual-ICE Cryoablation SystemBoston Scientific Corporation · 2023
- Descendant · 2 generations on · 4 of its ownK171398 Dermal Cooling SystemR2 Dermatology,Inc · 2017
- Descendant · 3 generations on · 3 of its ownK201260 Dermal Cooling SystemR2 Technologies, Inc. · 2020
- Descendant · 4 generations on · 2 of its ownK203006 R2 Dermabrasion Tip (for Dermal Cooling System)R2 Technologies, Inc. · 2021
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K161480R2 Dermal Cooling SystemR2 Dermatology · 2016 · cites it directly5descendants
- K230551Visual-ICE Cryoablation SystemBoston Scientific Corporation · 2023 · cites it directly4descendants
- K171398Dermal Cooling SystemR2 Dermatology,Inc · 2017 · 2 generations on4descendants
- K201260Dermal Cooling SystemR2 Technologies, Inc. · 2020 · 3 generations on3descendants
- K203006R2 Dermabrasion Tip (for Dermal Cooling System)R2 Technologies, Inc. · 2021 · 4 generations on2descendants
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 | K121251 | Icerod CX Cryoablation Needle Icerod CX Cryoablation Needle Multipack | Galil Medical, Ltd. | 2012 | 1 |
| −1 | K140584 | Icerod CX Cryoablation Needle | Galil Medical, Ltd. | 2014 | — |
| 0 (this device) | K152133 | IcePearl 2.1 CX Cryoablation Needle, IcePearl 2.1 CX Prostate Cryoablation Kit… | Galil Medical, Ltd. | 2015 | — |
| +1 | K161480 | R2 Dermal Cooling System | R2 Dermatology | 2016 | — |
| +1 | K230551 | Visual-ICE Cryoablation System | Boston Scientific Corporation | 2023 | — |
| +2 | K171398 | Dermal Cooling System | R2 Dermatology,Inc | 2017 | — |
| +3 | K201260 | Dermal Cooling System | R2 Technologies, Inc. | 2020 | — |
| +4 | K203006 | R2 Dermabrasion Tip (for Dermal Cooling System) | R2 Technologies, Inc. | 2021 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K121251 | Icerod CX Cryoablation Needle Icerod CX Cryoablation Needle MultipackSummary page 4…Cryosurgical unit and accessories (GEH) 21 CFR 878.4350 Predicate Devices / Reference IceRod CX Cryoablation Needles (K121251 and 510(k): K140584) IceEDGE 2.4 Cryoablation Needle (K11… | 2012 |
| * | K140584 | Icerod CX Cryoablation NeedleSummary page 4…21 CFR 878.4350 Predicate Devices / Reference IceRod CX Cryoablation Needles (K121251 and 510(k): K140584) IceEDGE 2.4 Cryoablation Needle (K111859) Visual… | 2014 |
| * | K111859 | Iceedge 2.4 Cryoablation Needle,Iceedge 2.4 Cryoablation Needle MultipackSummary page 4…IceRod CX Cryoablation Needles (K121251 and 510(k): K140584) IceEDGE 2.4 Cryoablation Needle (K111859) Visual-ICE Cryoablation System (K113860, K123865,… | 2011 |
| † | K113860 | Visual-Ice Cryoablation System | 2012 |
| † | K123865 | Visual-Ice Cryoablation System | 2013 |
| † | K143564 | Visual-ICE Cryoablation System, Software Revision 1.3.1 | 2015 |
What descends from it? (13)
See all 134 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 |
|---|---|---|---|---|
| Nov 18, 2020 | Class II | Z-0660-2021 | Under Investigation by firm | Complaint trend regarding needle shaft gas leaks. |
| Nov 18, 2020 | Class II | Z-0661-2021 | Under Investigation by firm | Complaint trend regarding needle shaft gas leaks. |
| Nov 18, 2020 | Class II | Z-0682-2021 | Under Investigation by firm | Complaint trend regarding needle shaft gas leaks. |
| Nov 18, 2020 | Class II | Z-0657-2021 | Under Investigation by firm | Complaint trend regarding needle shaft gas leaks. |
| Nov 18, 2020 | Class II | Z-0658-2021 | Under Investigation by firm | Complaint trend regarding needle shaft gas leaks. |
| Nov 18, 2020 | Class II | Z-0685-2021 | Under Investigation by firm | Complaint trend regarding needle shaft gas leaks. |
| Nov 18, 2020 | Class II | Z-0683-2021 | Under Investigation by firm | Complaint trend regarding needle shaft gas leaks. |
| Nov 18, 2020 | Class II | Z-0684-2021 | Under Investigation by firm | Complaint trend regarding needle shaft gas leaks. |
| Jun 4, 2020 | Class II | Z-2683-2020 | Nonconforming Material/Component | The needle surface deteriorated due to unexpected electrolysis during procedure. |
| Jun 4, 2020 | Class II | Z-2678-2020 | Nonconforming Material/Component | The needle surface deteriorated due to unexpected electrolysis during procedure. |
| Jun 4, 2020 | Class II | Z-2681-2020 | Nonconforming Material/Component | The needle surface deteriorated due to unexpected electrolysis during procedure. |
| Jun 4, 2020 | Class II | Z-2679-2020 | Nonconforming Material/Component | The needle surface deteriorated due to unexpected electrolysis during procedure. |
| Jun 4, 2020 | Class II | Z-2682-2020 | Nonconforming Material/Component | The needle surface deteriorated due to unexpected electrolysis during procedure. |
| Jun 4, 2020 | Class II | Z-2680-2020 | Nonconforming Material/Component | The needle surface deteriorated due to unexpected electrolysis during procedure. |
| Jun 4, 2020 | Class II | Z-2676-2020 | Nonconforming Material/Component | The needle surface deteriorated due to unexpected electrolysis during procedure. |
| Jun 4, 2020 | Class II | Z-2677-2020 | Nonconforming Material/Component | The needle surface deteriorated due to unexpected electrolysis during procedure. |
| Jun 4, 2020 | Class II | Z-2675-2020 | Nonconforming Material/Component | The needle surface deteriorated due to unexpected electrolysis during procedure. |
| Jun 4, 2020 | Class II | Z-2674-2020 | Nonconforming Material/Component | The needle surface deteriorated due to unexpected electrolysis during procedure. |
The 5 latest of 18 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 1 company; a new generation was cleared every 1.4 years on median.
- 10 of the 21 ancestors have a recall of any class.
- Of its descendants, K161480 (R2 Dermatology, 2016) has gone furthest, with 5 descendants of its own.
- 3 other devices also cite its predicate K121251.
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?
Galil Medical’s IcePearl 2.1 CX and IceFORCE 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures. The IcePearl 2.1 CX and IceFORCE 2.1 CX Cryoablation Needles are 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…
Read the full statement (268 words)
Galil Medical’s IcePearl 2.1 CX and IceFORCE 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures. The IcePearl 2.1 CX and IceFORCE 2.1 CX Cryoablation Needles are 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 systems are designed to destroy tissue by the application of extreme cold temperatures including prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts.
The Galil Medical IcePearl 2.1 CX and IceFORCE 2.1 CX Cryoablation Needles have 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 hemanglomas, mucocele cysts, multiple warts, plantar warts, actinic and seborrheic keratoses, cavernous hemanglomas, perianal 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 fibroadenoma)
• 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, and hemorrhoids)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152133 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152133: IcePearl 2.1 CX Cryoablation Needle, IcePearl 2.1 CX Prostate Cryoablation Kit Visual-ICE System, IceFORCE 2.1 CX Cryoablation Needle, IceFORCE 2.1 CX Prostate Cryoablation Kit Visual-ICE System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152133
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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