510(k) · Cleared
Recalled · Class II · 2020Iceedge 2.4 Cryoablation Needle,Iceedge 2.4 Cryoablation Needle Multipack
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 Oct 7, 2011 as substantially equivalent to K060144 (Galil Medical, Ltd., 2006) and 2 other predicates after a 99-day review. Its family tree reaches back 3 generations to 2000. 19 later devices descend from it. It has been recalled once.
- Decided
- Oct 7, 2011
- Review
- 99 days
- Class
- Class II
- Product code
- GEH
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 3 generations to K003065 (2000). 6 ancestors in all, the oldest K942299 (1995). 19 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK003065 Seednet, Model EP6T5, EP5E5Galil Medical, Ltd. · 2000 · Recalled
- 2 generations backK051052 Seednet Family (Seednet/Seedgold System, Cryothera System, Cryo-Hit…Galil Medical, Ltd. · 2005 · Recalled
- 1 generation backK110946 Icerod Plus 17G Cryoablation Needle, Icerod Plus 17G 90*…Galil Medical, Ltd. · 2011 · Recalled
- This deviceK111859 Iceedge 2.4 Cryoablation Needle,Iceedge 2.4 Cryoablation Needle…Galil Medical, Inc. · 2011
- 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 · 2 generations on · 5 of its ownK161480 R2 Dermal Cooling SystemR2 Dermatology · 2016
- Descendant · cites it directly · 5 of its ownK153489 Cryocare CS Surgical SystemHealthtronics · 2016
- Descendant · 2 generations on · 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
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K152133IcePearl 2.1 CX Cryoablation Needle, IcePearl 2.1 CX Prostate Cryoablation Kit…Galil Medical, Ltd. · 2015 · cites it directly13descendants
- K161480R2 Dermal Cooling SystemR2 Dermatology · 2016 · 2 generations on5descendants
- K153489Cryocare CS Surgical SystemHealthtronics · 2016 · cites it directly5descendants
- K230551Visual-ICE Cryoablation SystemBoston Scientific Corporation · 2023 · 2 generations on4descendants
- K201588CRYOCARE TOUCH System and Accessories, Endocare 1.7mm Round Ice PerCryo Cryoprobe…Varian Medical Systems, Inc. · 2020 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K003065 | Seednet, Model EP6T5, EP5E5 | Galil Medical, Ltd. | 2000 | 1 |
| −2 | K051052 | Seednet Family (Seednet/Seedgold System, Cryothera System, Cryo-Hit System) | Galil Medical, Ltd. | 2005 | 7 |
| −1 | K110946 | Icerod Plus 17G Cryoablation Needle, Icerod Plus 17G 90* Cryoablation Needle | Galil Medical, Ltd. | 2011 | 2 |
| 0 (this device) | K111859 | Iceedge 2.4 Cryoablation Needle,Iceedge 2.4 Cryoablation Needle Multipack | Galil Medical, Inc. | 2011 | — |
| +1 | K152133 | IcePearl 2.1 CX Cryoablation Needle, IcePearl 2.1 CX Prostate Cryoablation Kit… | Galil Medical, Ltd. | 2015 | 18 |
| +2 | K161480 | R2 Dermal Cooling System | R2 Dermatology | 2016 | — |
| +1 | K153489 | Cryocare CS Surgical System | Healthtronics | 2016 | — |
| +2 | 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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 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? (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 |
|---|---|---|---|
| * | K060144 | Seednet/Seednetgold, Cryothera and Cryo-Hit SystemsSummary page 1…Cryosurgical unit and accessories (GEH) Name: 21 CFR 878.4350 Predicate Devices: IceRod 17G 900 Cryoablation Needle (K0601 44) IceRod PLUS 17G Cryoablation Needles (K1 10946) ENDO… | 2006 |
| * | K110946 | Icerod Plus 17G Cryoablation Needle, Icerod Plus 17G 90* Cryoablation NeedleSummary page 1…878.4350 Predicate Devices: IceRod 17G 900 Cryoablation Needle (K0601 44) IceRod PLUS 17G Cryoablation Needles (K1 10946) ENDOcare PerCryo Renal Cryoprobe, an accessory to the… | 2011 |
| * | K963826 | Endocare Crycare Cryosurgical SystemSummary page 1…K1 10946) ENDOcare PerCryo Renal Cryoprobe, an accessory to the CRYOcare Cryosurgical System (K963826) Device Description: The IceEDGE 2.4 Cryoablation Needle is a sterile, single use, disposable component used in conjunction with… | 1996 |
What descends from it? (19)
See all 192 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-0677-2021 | 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 2 companies; a new generation was cleared every 4.5 years on median.
- 4 of the 6 ancestors have a recall of any class.
- Of its descendants, K152133 (Galil Medical, Ltd., 2015) has gone furthest, with 13 descendants of its own.
- 1 other device also cites its predicate K060144.
How does its category compare?
All GEH devicesGEH Unit, Cryosurgical, Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
Gaul Medical Cryoablation Systems are intended for cryoablative destruction of tissue during surgical procedures. The cryoablation systems are 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 systems are designed to destroy tissue by the application of extreme cold temperatures including prostate and kidney…
Read the full statement (233 words)
Gaul Medical Cryoablation Systems are intended for cryoablative destruction of tissue during surgical procedures. The cryoablation systems are 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 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.
Galil Medical Cryoablation Systems 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, angiomnas, 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 hemanglornas, perianal condylomata, and palliation of tumors of the skin.)
*Gynecology (ablation of malignant neoplasia or benign dlysplasia 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 (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/K111859 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111859: Iceedge 2.4 Cryoablation Needle,Iceedge 2.4 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/K111859
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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