510(k) · Cleared
Recalled · Class II · 2025IceSeed 1.5 CX 90º Needle (H7493967433170); IceSeed 1.5 CX S 90º Needle (H7493967233100)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific · GEH Unit, Cryosurgical, Accessories
Cleared on Nov 22, 2023 as substantially equivalent to K181741 (Galil Medical, Ltd., 2018) and 1 other predicate after an 84-day review. Its family tree reaches back 10 generations to 2001. 1 later device descends from it. It has been recalled once.
- Decided
- Nov 22, 2023
- Review
- 84 days
- Class
- Class II
- Product code
- GEH
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 10 generations to K010991 (2001). 28 ancestors in all, the oldest K942299 (1995). 1 later device descends from it, 1 citing it directly.
- Root · 10 generations backK010991 Seednet, Models FP6T5, FP5T5, FP5T3Galil Medical, Ltd. · 2001 · Recalled
- 6 generations between
- 3 generations backK123865 Visual-Ice Cryoablation SystemGalil Medical, Inc. · 2013 · Recalled
- 2 generations backK143564 Visual-ICE Cryoablation System, Software Revision 1.3.1Galil Medical, Inc. · 2015 · Recalled
- 1 generation backK230551 Visual-ICE Cryoablation SystemBoston Scientific Corporation · 2023
- This deviceK232635 IceSeed 1.5 CX 90º Needle (H7493967433170); IceSeed 1.5 CX S 90º…Boston Scientific · 2023
- Descendant · cites it directly · 0 of its ownK243245 IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1.5 CX…Boston Scientific Corp · 2024
Show all 10 generations
- Root · 10 generations backK010991 Seednet, Models FP6T5, FP5T5, FP5T3Galil Medical, Ltd. · 2001 · Recalled
- 9 generations backK011950 Seednet, Model FP6T5, FP5T5, FP5T3Galil Medical, Ltd. · 2002
- 8 generations backK021261 Seednet System and Seednetgold System, Models GP6T5, GP5T5, GP5T3…Galil Medical, Ltd. · 2002 · Recalled
- 7 generations backK031117 Seednet System and Seednetgold SystemGalil Medical, Ltd. · 2003
- 6 generations backK042667 Seednet Gold with Renal Kit, Model Fprpr 3021, (Renal Kit), Fprch…Galil Medical, Ltd. · 2004
- 5 generations backK060390 Seednet, Seednet Gold, Cryohit, Cryo TheraGalil Medical, Ltd. · 2006 · Recalled
- 4 generations backK113860 Visual-Ice Cryoablation SystemGalil Medical, Inc. · 2012 · Recalled
- 3 generations backK123865 Visual-Ice Cryoablation SystemGalil Medical, Inc. · 2013 · Recalled
- 2 generations backK143564 Visual-ICE Cryoablation System, Software Revision 1.3.1Galil Medical, Inc. · 2015 · Recalled
- 1 generation backK230551 Visual-ICE Cryoablation SystemBoston Scientific Corporation · 2023
- This deviceK232635 IceSeed 1.5 CX 90º Needle (H7493967433170); IceSeed 1.5 CX S 90º…Boston Scientific · 2023
Most influential descendants
Showing 1 of 1 · See all- K243245IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1.5 CX Straight Needle…Boston Scientific Corp · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K010991 | Seednet, Models FP6T5, FP5T5, FP5T3 | Galil Medical, Ltd. | 2001 | 2 |
| −9 | K011950 | Seednet, Model FP6T5, FP5T5, FP5T3 | Galil Medical, Ltd. | 2002 | — |
| −8 | K021261 | Seednet System and Seednetgold System, Models GP6T5, GP5T5, GP5T3, HP5T5 & HP5T3 | Galil Medical, Ltd. | 2002 | 1 |
| −7 | K031117 | Seednet System and Seednetgold System | Galil Medical, Ltd. | 2003 | — |
| −6 | K042667 | Seednet Gold with Renal Kit, Model Fprpr 3021, (Renal Kit), Fprch 2024… | Galil Medical, Ltd. | 2004 | — |
| −5 | K060390 | Seednet, Seednet Gold, Cryohit, Cryo Thera | Galil Medical, Ltd. | 2006 | 8 |
| −4 | K113860 | Visual-Ice Cryoablation System | Galil Medical, Inc. | 2012 | 2 |
| −3 | K123865 | Visual-Ice Cryoablation System | Galil Medical, Inc. | 2013 | 1 |
| −2 | K143564 | Visual-ICE Cryoablation System, Software Revision 1.3.1 | Galil Medical, Inc. | 2015 | 1 |
| −1 | K230551 | Visual-ICE Cryoablation System | Boston Scientific Corporation | 2023 | — |
| 0 (this device) | K232635 | IceSeed 1.5 CX 90º Needle (H7493967433170); IceSeed 1.5 CX S 90º Needle… | Boston Scientific | 2023 | — |
| +1 | K243245 | IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1.5 CX Straight… | Boston Scientific Corp | 2024 | — |
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 |
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 |
|---|---|---|---|
| * | K181741 | IceSphere 1.5 CX Cryoablation NeedleSummary page 6…Regulation Number: 21 CFR 878.4350 Product Code: GEH Predicate Device 510(k): IceSphere CX Cryoablation Needle (K181741) IceSeed 90º Cryoablation Needle (K060144) Visual… | 2018 |
| * | K230551 | Visual-ICE Cryoablation SystemSummary page 6…eedle (K181741) IceSeed 90º Cryoablation Needle (K060144) Visual-ICE Cryoablation System (K230551) Date of Preparation: November 21, 2023 Device Description: Boston Scientific Corporation’s (BSC) IceSeed 1.5… | 2023 |
| † | K060144 | Seednet/Seednetgold, Cryothera and Cryo-Hit Systems | 2006 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K243245 | IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1.5 CX Straight Needle… | 2024 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 24, 2025 | Class II | Z-1686-2025 | Process control | Boston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and February 2025 have been programmed with DEMO settings instead of Commercial settings (see Affected Product Listing). Upon initial connection of… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 4 companies; a new generation was cleared every 1.4 years on median.
- 16 of the 28 ancestors have a recall of any class.
- Of its descendants, K243245 (Boston Scientific Corp, 2024) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K181741.
How does its category compare?
All GEH devicesGEH Unit, Cryosurgical, Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 Boston Scientific disposable IceRod Cryoablation Needle, IceSphere Cryoablation Needle, IceSeed Cryoablation Needle, IcePearl Cryoablation Needle, and IceForce Cryoablation Needle (CX Needles), when used with a Boston Scientific ICEfx Cryoablation System or Visual-ICE Cryoablation System, are designed to destroy tissue by the application of extremely cold temperatures. The Boston Scientific CX Needles, when used with ICEfx Cryoablation System or…
Read the full statement (339 words)
The Boston Scientific disposable IceRod Cryoablation Needle, IceSphere Cryoablation Needle, IceSeed Cryoablation Needle, IcePearl Cryoablation Needle, and IceForce Cryoablation Needle (CX Needles), when used with a Boston Scientific ICEfx Cryoablation System or Visual-ICE Cryoablation System, are designed to destroy tissue by the application of extremely cold temperatures.
The Boston Scientific CX Needles, when used with ICEfx Cryoablation System or Visual-ICE Cryoablation System, 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 CX Needles are designed to destroy tissue (including prostate and kidney tissue, liver metastases, tumors, and skin lesions) by the application of extremely cold temperatures.
The CX 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 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, 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 – (with the exception of cardiac tissue)
• Proctology – Ablation of benign or malignant growths of the anus or rectum
Additionally, when used with the Visual-ICE Cryoablation System, the CX Needles are indicated for use in the field of Oncology for palliation of pain associated with metastatic lesions involving bone in patients who have failed or are not candidates for standard radiation therapy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232635 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232635: IceSeed 1.5 CX 90º Needle (H7493967433170); IceSeed 1.5 CX S 90º Needle (H7493967233100).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232635
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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