510(k) · Cleared

Recalled · Class II · 2020

Seednet Family (Seednet/Seedgold System, Cryothera System, Cryo-Hit System)

K051052510(k) SpecialCleared May 6, 200511-day reviewClass II21 CFR 878.4350Recalls 7

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Galil Medical, Ltd. · GEH Unit, Cryosurgical, Accessories

Cleared on May 6, 2005 as substantially equivalent to K003065 (Galil Medical, Ltd., 2000) after an 11-day review. Its family tree reaches back 1 generation to 2000. 31 later devices descend from it. It has been recalled 7 times.

Decided: May 6, 2005
Review: 11 days
Class: Class II
Product code: GEH
Recalls: 7
Predicates: 2

Its longest line of descent runs back 1 generation to K003065 (2000). 31 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK003065 Seednet, Model EP6T5, EP5E5Galil Medical, Ltd. · 2000 · Recalled
This deviceK051052 Seednet Family (Seednet/Seedgold System, Cryothera System, Cryo-Hit…Galil Medical, Ltd. · 2005
Descendant · cites it directly · 28 of its ownK060390 Seednet, Seednet Gold, Cryohit, Cryo TheraGalil Medical, Ltd. · 2006 · Recalled
Descendant · cites it directly · 25 of its ownK110946 Icerod Plus 17G Cryoablation Needle, Icerod Plus 17G 90*…Galil Medical, Ltd. · 2011 · Recalled
Descendant · 2 generations on · 22 of its ownK121251 Icerod CX Cryoablation Needle Icerod CX Cryoablation Needle MultipackGalil Medical, Ltd. · 2012 · Recalled
Descendant · 3 generations on · 20 of its ownK140584 Icerod CX Cryoablation NeedleGalil Medical, Ltd. · 2014
Descendant · 2 generations on · 19 of its ownK111859 Iceedge 2.4 Cryoablation Needle,Iceedge 2.4 Cryoablation Needle…Galil Medical, Inc. · 2011 · Recalled

Showing 5 of 31 descendants. See all descendants

Descendants cleared per year

2006high 4 (2023) · low 0 (2007)2026

Most influential descendants

Showing 5 of 31 · See all

K060390Seednet, Seednet Gold, Cryohit, Cryo TheraGalil Medical, Ltd. · 2006 · cites it directly28descendants
K110946Icerod Plus 17G Cryoablation Needle, Icerod Plus 17G 90* Cryoablation NeedleGalil Medical, Ltd. · 2011 · cites it directly25descendants
K121251Icerod CX Cryoablation Needle Icerod CX Cryoablation Needle MultipackGalil Medical, Ltd. · 2012 · 2 generations on22descendants
K140584Icerod CX Cryoablation NeedleGalil Medical, Ltd. · 2014 · 3 generations on20descendants
K111859Iceedge 2.4 Cryoablation Needle,Iceedge 2.4 Cryoablation Needle MultipackGalil Medical, Inc. · 2011 · 2 generations on19descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K003065	Seednet, Model EP6T5, EP5E5	Galil Medical, Ltd.	2000	1
0 (this device)	K051052	Seednet Family (Seednet/Seedgold System, Cryothera System, Cryo-Hit System)	Galil Medical, Ltd.	2005	—
+1	K060390	Seednet, Seednet Gold, Cryohit, Cryo Thera	Galil Medical, Ltd.	2006	8
+1	K110946	Icerod Plus 17G Cryoablation Needle, Icerod Plus 17G 90* Cryoablation Needle	Galil Medical, Ltd.	2011	2
+2	K121251	Icerod CX Cryoablation Needle Icerod CX Cryoablation Needle Multipack	Galil Medical, Ltd.	2012	1
+3	K140584	Icerod CX Cryoablation Needle	Galil Medical, Ltd.	2014	—
+2	K111859	Iceedge 2.4 Cryoablation Needle,Iceedge 2.4 Cryoablation Needle Multipack	Galil Medical, Inc.	2011	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2009	1	0
2011	2	0
2012	2	0
2013	1	0
2014	2	0
2015	2	0
2016	3	0
2017	1	0
2018	2	0
2020	3	0
2021	1	0
2022	1	0
2023	4	0
2024	2	0
2025	2	0
2026	1	0

FIG. 1 — Lineage of K051052, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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

Get a 510(k) 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

Type	Number	Device	Applicant	Decided	Recalls
Kept off the family tree	K003117	SeedNet System Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree
*	K003065	Seednet, Model EP6T5, EP5E5 Summary page 1 …SeedNetGold"1', which are cryosurgical units with argon-cooled Cryoprobes, as Class II devices (KO031117, K(003065, 1(010991, K0l1950, and 1(021261). Therefore, cryosurgical units with argon- cooled pro…	Galil Medical, Ltd.	2000	1
*	—	Cryo-Hit System Named without a submission number			—

Also cleared against K003065: 1 other device →

What descends from it? (31)

See all 31

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K060390	Seednet, Seednet Gold, Cryohit, Cryo Thera	Galil Medical, Ltd.	2006	28
K110946	Icerod Plus 17G Cryoablation Needle, Icerod Plus 17G 90* Cryoablation Needle	Galil Medical, Ltd.	2011	25

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-0669-2021	Under Investigation by firm	Complaint trend regarding needle shaft gas leaks.
Nov 18, 2020	Class II	Z-0680-2021	Under Investigation by firm	Complaint trend regarding needle shaft gas leaks.
Nov 18, 2020	Class II	Z-0678-2021	Under Investigation by firm	Complaint trend regarding needle shaft gas leaks.
Nov 18, 2020	Class II	Z-0679-2021	Under Investigation by firm	Complaint trend regarding needle shaft gas leaks.
Nov 18, 2020	Class II	Z-0681-2021	Under Investigation by firm	Complaint trend regarding needle shaft gas leaks.
Nov 18, 2020	Class II	Z-0688-2021	Under Investigation by firm	Complaint trend regarding needle shaft gas leaks.
Dec 20, 2010	Not classified	Z-1032-2011	Device Design	This voluntary correction has been initiated due to the discovery of a damaged optocoupler on one of our Presice Systems during periodic preventive maintenance. The optocoupler sends a signal across the locking mechanism in the Presice…

The 5 latest of 7 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has a recall.
Of its descendants, K060390 (Galil Medical, Ltd., 2006) has gone furthest, with 28 descendants of its own.
1 other device also cites its predicate K003065.

How does its category compare?

All GEH devices

GEH Unit, Cryosurgical, Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GEH

10in 2025

2007high 15 (2016) · low 1 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEH

77in 2025

2007high 206 (2021) · low 42 (2014)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GEH

2in 2023

2007high 37 (2020) · low 0 (2011)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · GEH

171in 2025

2007high 455 (2019) · low 21 (2009)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 SeedNet System is intended for cryogenic destruction of tissue during surgical procedures. It 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 prostate and kidney tissue, liver metastases, tumors, skin…

Read the full statement (260 words)

The SeedNet System is intended for cryogenic destruction of tissue during surgical procedures.

It 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 prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts.

The SeedNet System 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 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.)

* ENT (Palliation of tumors of the oral cavity and ablation of leukoplakia of the mouth).

* Thoracic surgery (ablation of arrhythmic cardiac tissue and cancerous lesions,)

* Proctology (ablation of benign or malignant growths of the anus or rectum and hemorrhoids)

The SeedNet System may be used with a magnetic resonance imaging (MRI) device or an ultrasound device to provide real-time visualization of the cryosurgical procedure.

Indications for use as stated in the FDA 510(k) statement.

https://510kreport.com/device/K051052 · printed Nov 4, 2026

Cite this page

510(k) Report. “K051052: Seednet Family (Seednet/Seedgold System, Cryothera System, Cryo-Hit System).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K051052

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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