510(k) · Cleared
Recalled · Class II · 2020Icerod CX Cryoablation Needle Icerod CX Cryoablation Needle Multipack
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, 2012 as substantially equivalent to K110946 (Galil Medical, Ltd., 2011) and 1 other predicate after a 125-day review. Its family tree reaches back 6 generations to 2001. 22 later devices descend from it. It has been recalled once.
- Decided
- Aug 28, 2012
- Review
- 125 days
- Class
- Class II
- Product code
- GEH
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 6 generations to K010991 (2001). 16 ancestors in all, the oldest K980913 (1998). 22 later devices descend from it, 4 citing it directly.
- Root · 6 generations backK010991 Seednet, Models FP6T5, FP5T5, FP5T3Galil Medical, Ltd. · 2001 · Recalled
- 5 generations backK011950 Seednet, Model FP6T5, FP5T5, FP5T3Galil Medical, Ltd. · 2002
- 4 generations backK021261 Seednet System and Seednetgold System, Models GP6T5, GP5T5, GP5T3…Galil Medical, Ltd. · 2002 · Recalled
- 3 generations backK031117 Seednet System and Seednetgold SystemGalil Medical, Ltd. · 2003
- 2 generations backK042667 Seednet Gold with Renal Kit, Model Fprpr 3021, (Renal Kit), Fprch…Galil Medical, Ltd. · 2004
- 1 generation backK060390 Seednet, Seednet Gold, Cryohit, Cryo TheraGalil Medical, Ltd. · 2006 · Recalled
- This deviceK121251 Icerod CX Cryoablation Needle Icerod CX Cryoablation Needle MultipackGalil Medical, Ltd. · 2012
- Descendant · cites it directly · 20 of its ownK140584 Icerod CX Cryoablation NeedleGalil Medical, Ltd. · 2014
- Descendant · cites it directly · 13 of its ownK152133 IcePearl 2.1 CX Cryoablation Needle, IcePearl 2.1 CX Prostate…Galil Medical, Ltd. · 2015 · Recalled
- Descendant · cites it directly · 10 of its ownK143564 Visual-ICE Cryoablation System, Software Revision 1.3.1Galil Medical, Inc. · 2015 · Recalled
- Descendant · 2 generations on · 5 of its ownK161480 R2 Dermal Cooling SystemR2 Dermatology · 2016
- Descendant · 2 generations on · 5 of its ownK153489 Cryocare CS Surgical SystemHealthtronics · 2016
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K140584Icerod CX Cryoablation NeedleGalil Medical, Ltd. · 2014 · cites it directly20descendants
- K152133IcePearl 2.1 CX Cryoablation Needle, IcePearl 2.1 CX Prostate Cryoablation Kit…Galil Medical, Ltd. · 2015 · cites it directly13descendants
- K143564Visual-ICE Cryoablation System, Software Revision 1.3.1Galil Medical, Inc. · 2015 · cites it directly10descendants
- K161480R2 Dermal Cooling SystemR2 Dermatology · 2016 · 2 generations on5descendants
- K153489Cryocare CS Surgical SystemHealthtronics · 2016 · 2 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K010991 | Seednet, Models FP6T5, FP5T5, FP5T3 | Galil Medical, Ltd. | 2001 | 2 |
| −5 | K011950 | Seednet, Model FP6T5, FP5T5, FP5T3 | Galil Medical, Ltd. | 2002 | — |
| −4 | K021261 | Seednet System and Seednetgold System, Models GP6T5, GP5T5, GP5T3, HP5T5 & HP5T3 | Galil Medical, Ltd. | 2002 | 1 |
| −3 | K031117 | Seednet System and Seednetgold System | Galil Medical, Ltd. | 2003 | — |
| −2 | K042667 | Seednet Gold with Renal Kit, Model Fprpr 3021, (Renal Kit), Fprch 2024… | Galil Medical, Ltd. | 2004 | — |
| −1 | K060390 | Seednet, Seednet Gold, Cryohit, Cryo Thera | Galil Medical, Ltd. | 2006 | 8 |
| 0 (this device) | K121251 | Icerod CX Cryoablation Needle Icerod CX Cryoablation Needle Multipack | Galil Medical, Ltd. | 2012 | — |
| +1 | K140584 | Icerod CX Cryoablation Needle | Galil Medical, Ltd. | 2014 | — |
| +1 | K152133 | IcePearl 2.1 CX Cryoablation Needle, IcePearl 2.1 CX Prostate Cryoablation Kit… | Galil Medical, Ltd. | 2015 | 18 |
| +1 | K143564 | Visual-ICE Cryoablation System, Software Revision 1.3.1 | Galil Medical, Inc. | 2015 | 1 |
| +2 | K161480 | R2 Dermal Cooling System | R2 Dermatology | 2016 | — |
| +2 | K153489 | Cryocare CS Surgical System | Healthtronics | 2016 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 4 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 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? (2)
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 |
|---|---|---|---|
| * | K110946 | Icerod Plus 17G Cryoablation Needle, Icerod Plus 17G 90* Cryoablation NeedleSummary page 1…Cryosurgical unit and accessories (GEH) Name: 21 CFR 878.4350 Predicate Devices IIceRod PLUS 17G Cryoablation Needles (K1 10946) Referenced 510(k): IceRod i-Thaw 17G Cryoablation Needles (K060390) Device Description: The IceRod CX Cryoablation N… | 2011 |
| * | K060390 | Seednet, Seednet Gold, Cryohit, Cryo TheraSummary page 1…21 CFR 878.4350 Predicate Devices IIceRod PLUS 17G Cryoablation Needles (K1 10946) Referenced 510(k): IceRod i-Thaw 17G Cryoablation Needles (K060390) Device Description: The IceRod CX Cryoablation Needle is a sterile, single use, disposable component used in conjunction with… | 2006 |
What descends from it? (22)
See all 224 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-0663-2021 | Under Investigation by firm | Complaint trend regarding needle shaft gas leaks. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 1 company; a new generation was cleared every 1.4 years on median.
- 8 of the 16 ancestors have a recall of any class.
- Of its descendants, K140584 (Galil Medical, Ltd., 2014) has gone furthest, with 20 descendants of its own.
- 2 other devices also cite its predicate K110946.
How does its category compare?
All GEH devicesGEH Unit, Cryosurgical, Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 Gal ii Medical IceRod CX Cryoablation Needle is intended for crycablative destruction of tissue during surgical procedures. The IceRod CX Cryoablation Needle 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 systems are designed to destroy tissue by the…
Read the full statement (247 words)
The Gal ii Medical IceRod CX Cryoablation Needle is intended for crycablative destruction of tissue during surgical procedures. The IceRod CX Cryoablation Needle 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 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 IceRod CX Cryoablation Needle 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 hemanglomas, mucocele cysts, multiple warts, plantar warts, actinic and seborrheic keratoses, cavernous hemanglomas, perianal condylomnata, 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/K121251 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121251: Icerod CX Cryoablation Needle Icerod CX Cryoablation Needle Multipack.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121251
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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