510(k) Report

510(k) · Cleared

Recalled · Class II · 2020

Seednet, Model EP6T5, EP5E5

K003065510(k) SpecialCleared Oct 31, 200029-day reviewClass II21 CFR 878.4350Recalls 1

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 Oct 31, 2000 after a 29-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 32 later devices descend from it. It has been recalled once.

Decided
Oct 31, 2000
Review
29 days
Class
Class II
Product code
GEH
Recalls
1
Predicates
0

32 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2005: 1 descendant cleared2006: 1 descendant cleared2011: 2 descendants cleared2009: 1 descendant cleared2012: 2 descendants cleared2014: 2 descendants cleared2013: 1 descendant cleared2023: 4 descendants cleared2015: 2 descendants cleared2018: 2 descendants cleared2016: 3 descendants cleared2024: 2 descendants cleared2020: 3 descendants cleared2025: 2 descendants cleared2017: 1 descendant cleared2021: 1 descendant cleared2022: 1 descendant cleared2026: 1 descendant cleared200020052010201520202025
  1. This deviceK003065 Seednet, Model EP6T5, EP5E5Galil Medical, Ltd. · 2000
  2. Descendant · cites it directly · 31 of its ownK051052 Seednet Family (Seednet/Seedgold System, Cryothera System, Cryo-Hit…Galil Medical, Ltd. · 2005 · Recalled
  3. Descendant · cites it directly · 28 of its ownK060390 Seednet, Seednet Gold, Cryohit, Cryo TheraGalil Medical, Ltd. · 2006 · Recalled
  4. Descendant · 2 generations on · 25 of its ownK110946 Icerod Plus 17G Cryoablation Needle, Icerod Plus 17G 90*…Galil Medical, Ltd. · 2011 · Recalled
  5. Descendant · 2 generations on · 22 of its ownK121251 Icerod CX Cryoablation Needle Icerod CX Cryoablation Needle MultipackGalil Medical, Ltd. · 2012 · Recalled
  6. Descendant · 3 generations on · 20 of its ownK140584 Icerod CX Cryoablation NeedleGalil Medical, Ltd. · 2014

Showing 5 of 32 descendants. See all descendants

Descendants cleared per year

2005: 12006: 12009: 12011: 22012: 22013: 12014: 22015: 22016: 32017: 12018: 22020: 32021: 12022: 12023: 42024: 22025: 22026: 1
2005high 4 (2023) · low 0 (2007)2026

Most influential descendants

Showing 5 of 32 · See all
  • K051052Seednet Family (Seednet/Seedgold System, Cryothera System, Cryo-Hit System)Galil Medical, Ltd. · 2005 · cites it directly31descendants
  • 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 · 2 generations on25descendants
  • 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
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K003065Seednet, Model EP6T5, EP5E5Galil Medical, Ltd.2000—
+1K051052Seednet Family (Seednet/Seedgold System, Cryothera System, Cryo-Hit System)Galil Medical, Ltd.20057
+1K060390Seednet, Seednet Gold, Cryohit, Cryo TheraGalil Medical, Ltd.20068
+2K110946Icerod Plus 17G Cryoablation Needle, Icerod Plus 17G 90* Cryoablation NeedleGalil Medical, Ltd.20112
+2K121251Icerod CX Cryoablation Needle Icerod CX Cryoablation Needle MultipackGalil Medical, Ltd.20121
+3K140584Icerod CX Cryoablation NeedleGalil Medical, Ltd.2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200610
200910
201120
201220
201310
201420
201520
201630
201710
201820
202030
202110
202210
202340
202420
202520
202610
FIG. 1 — Lineage of K003065, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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. #1 K211099 Freeze’n Clear Skin Clinic Warts & Tagsscore 25.4 · 4 generations · no Class I recall
  2. #2 Held for the reportin the report
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Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (32)

See all 32

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

NumberDeviceApplicantDecidedDescendants
K051052Seednet Family (Seednet/Seedgold System, Cryothera System, Cryo-Hit System)Galil Medical, Ltd.200531
K060390Seednet, Seednet Gold, Cryohit, Cryo TheraGalil Medical, Ltd.200628

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Nov 18, 2020Class IIZ-0676-2021Under Investigation by firmComplaint trend regarding needle shaft gas leaks.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K051052 (Galil Medical, Ltd., 2005) has gone furthest, with 31 descendants of its own.

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

2007: 62008: 12009: 42010: 42011: 72012: 42013: 42014: 62015: 112016: 152017: 122018: 62019: 62020: 82021: 62022: 62023: 82024: 92025: 102026 (partial year): 8
2007high 15 (2016) · low 1 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEH

77in 2025

2007: 71 days median2009: 121 days median2010: 86 days median2011: 91 days median2012: 96 days median2013: 76 days median2014: 42 days median2015: 72 days median2016: 60 days median2017: 83 days median2018: 42 days median2019: 115 days median2020: 113 days median2021: 206 days median2022: 56 days median2023: 136 days median2024: 85 days median2025: 77 days median2026 (partial year): 148 days median
2007high 206 (2021) · low 42 (2014)2026

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

Recalls per year · GEH

2in 2023

2007: 32008: 22009: 132010: 42012: 32014: 22018: 12019: 12020: 372023: 22026 (partial year): 2
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

2007: 232008: 292009: 212010: 1732011: 612012: 912013: 912014: 572015: 972016: 1432017: 2162018: 2082019: 4552020: 2772021: 2132022: 2302023: 1642024: 1412025: 171
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007671323
20081—229
200941211321
20104864173
2011791061
2012496391
2013476091
2014642257
20151172097
201615600143
201712830216
20186421208
201961151455
2020811337277
202162060213
20226560230
202381362164
20249850141
202510770171
202681482—

More from Galil Medical, Ltd.

23 FDA decisions under this applicant name. See the company

  • K181741IceSphere 1.5 CX Cryoablation NeedleGalil Medical, Ltd. · 20181 recall
  • K162599IcePearl 2.1 CX L, IceForce 2.1 CX LGalil Medical, Ltd. · 20162 recalls
  • K152133IcePearl 2.1 CX Cryoablation Needle, IcePearl 2.1 CX Prostate Cryoablation Kit Visual-ICE System, IceFORCE…Galil Medical, Ltd. · 201518 recalls
  • K141485Icesphere 1.5 90 Cryoblation Needle, Iceshpere 1.5 Cyoblation NeedleGalil Medical, Ltd. · 20143 recalls
  • K140584Icerod CX Cryoablation NeedleGalil Medical, Ltd. · 2014

Recent decisions in GEH

The GEH category page

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  • K261068Maverix Cryo Biopsy Probe (MCB1000);Maverix Cryo Cartridge (CC1000)Serpex Medical · 2026
  • K261806ERBECRYO 2 Cryosurgical Unit and AccessoriesErbe Elektromedizin GmbH · 2026
  • K253230ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible CryoprobeErbe Elektromedizin GmbH · 2026
  • K252198Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover)Medical Brands Laboratories B.V. · 2026

https://510kreport.com/device/K003065 · printed Nov 6, 2026

Cite this page

510(k) Report. “K003065: Seednet, Model EP6T5, EP5E5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003065

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026