510(k) · Cleared
Recalled · Class II · 2020Seednet, Seednet Gold, Cryohit, Cryo Thera
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 Apr 27, 2006 as substantially equivalent to K980913 (Galil Medical, Ltd., 1998) and 12 other predicates after a 72-day review. Its family tree reaches back 5 generations to 2001. 28 later devices descend from it. It has been recalled 8 times.
- Decided
- Apr 27, 2006
- Review
- 72 days
- Class
- Class II
- Product code
- GEH
- Recalls
- 8
- Predicates
- 13
Its longest line of descent runs back 5 generations to K010991 (2001). 13 ancestors in all, the oldest K980913 (1998). 28 later devices descend from it, 4 citing it directly.
- Root · 5 generations backK010991 Seednet, Models FP6T5, FP5T5, FP5T3Galil Medical, Ltd. · 2001 · Recalled
- 4 generations backK011950 Seednet, Model FP6T5, FP5T5, FP5T3Galil Medical, Ltd. · 2002
- 3 generations backK021261 Seednet System and Seednetgold System, Models GP6T5, GP5T5, GP5T3…Galil Medical, Ltd. · 2002 · Recalled
- 2 generations backK031117 Seednet System and Seednetgold SystemGalil Medical, Ltd. · 2003
- 1 generation backK042667 Seednet Gold with Renal Kit, Model Fprpr 3021, (Renal Kit), Fprch…Galil Medical, Ltd. · 2004
- This deviceK060390 Seednet, Seednet Gold, Cryohit, Cryo TheraGalil Medical, Ltd. · 2006
- Descendant · cites it directly · 22 of its ownK121251 Icerod CX Cryoablation Needle Icerod CX Cryoablation Needle MultipackGalil Medical, Ltd. · 2012 · Recalled
- Descendant · 2 generations on · 20 of its ownK140584 Icerod CX Cryoablation NeedleGalil Medical, Ltd. · 2014
- Descendant · cites it directly · 15 of its ownK113860 Visual-Ice Cryoablation SystemGalil Medical, Inc. · 2012 · Recalled
- Descendant · 2 generations on · 13 of its ownK152133 IcePearl 2.1 CX Cryoablation Needle, IcePearl 2.1 CX Prostate…Galil Medical, Ltd. · 2015 · Recalled
- Descendant · 2 generations on · 11 of its ownK123865 Visual-Ice Cryoablation SystemGalil Medical, Inc. · 2013 · Recalled
Showing 5 of 28 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 28 · See all- K121251Icerod CX Cryoablation Needle Icerod CX Cryoablation Needle MultipackGalil Medical, Ltd. · 2012 · cites it directly22descendants
- K140584Icerod CX Cryoablation NeedleGalil Medical, Ltd. · 2014 · 2 generations on20descendants
- K113860Visual-Ice Cryoablation SystemGalil Medical, Inc. · 2012 · cites it directly15descendants
- K152133IcePearl 2.1 CX Cryoablation Needle, IcePearl 2.1 CX Prostate Cryoablation Kit…Galil Medical, Ltd. · 2015 · 2 generations on13descendants
- K123865Visual-Ice Cryoablation SystemGalil Medical, Inc. · 2013 · 2 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K010991 | Seednet, Models FP6T5, FP5T5, FP5T3 | Galil Medical, Ltd. | 2001 | 2 |
| −4 | K011950 | Seednet, Model FP6T5, FP5T5, FP5T3 | Galil Medical, Ltd. | 2002 | — |
| −3 | K021261 | Seednet System and Seednetgold System, Models GP6T5, GP5T5, GP5T3, HP5T5 & HP5T3 | Galil Medical, Ltd. | 2002 | 1 |
| −2 | K031117 | Seednet System and Seednetgold System | Galil Medical, Ltd. | 2003 | — |
| −1 | K042667 | Seednet Gold with Renal Kit, Model Fprpr 3021, (Renal Kit), Fprch 2024… | Galil Medical, Ltd. | 2004 | — |
| 0 (this device) | K060390 | Seednet, Seednet Gold, Cryohit, Cryo Thera | Galil Medical, Ltd. | 2006 | — |
| +1 | K121251 | Icerod CX Cryoablation Needle Icerod CX Cryoablation Needle Multipack | Galil Medical, Ltd. | 2012 | 1 |
| +2 | K140584 | Icerod CX Cryoablation Needle | Galil Medical, Ltd. | 2014 | — |
| +1 | K113860 | Visual-Ice Cryoablation System | Galil Medical, Inc. | 2012 | 2 |
| +2 | K152133 | IcePearl 2.1 CX Cryoablation Needle, IcePearl 2.1 CX Prostate Cryoablation Kit… | Galil Medical, Ltd. | 2015 | 18 |
| +2 | K123865 | Visual-Ice Cryoablation System | Galil Medical, Inc. | 2013 | 1 |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 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 |
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? (13)
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 |
|---|---|---|---|
| * | K980913 | Cryo-Hit Model Numbers EP3T3, EP5T2, EP5T5, EP7T5, EP8T5Summary page 1…ryo-Hit®, SeedNet®, SeedNetGold® and CryoThera®, which are cryosurgical units with argon- cooled Cryoprobes, as Class II devices (K980913, K991272, K991517, K993965, K003065, K010991, K012497, K011950, K021261, K031117, K042667… | 1998 |
| * | K991272 | Cryo-Hit,Models ED1TO, Epiti, EP2TI, EP2T2, EP3T3, EP4T2, EPT3, EP4T4,EP5T2, EP5T3…Summary page 1…ld® and CryoThera®, which are cryosurgical units with argon- cooled Cryoprobes, as Class II devices (K980913, K991272, K991517, K993965, K003065, K010991, K012497, K011950, K021261, K031117, K042667, K051052… | 1999 |
| * | K991517 | Cryo-Hit II, Models EP3T3, EP5T2, EP5T5, EP7T5, EP8T5Summary page 1…CryoThera®, which are cryosurgical units with argon- cooled Cryoprobes, as Class II devices (K980913, K991272, K991517, K993965, K003065, K010991, K012497, K011950, K021261, K031117, K042667, K051052, K052530… | 1999 |
| * | K993965 | Cryo-HitSummary page 1…CryoThera®, which are cryosurgical units with argon- cooled Cryoprobes, as Class II devices (K980913, K991272, K991517, K993965, K003065, K010991, K012497, K011950, K021261, K031117, K042667, K051052, K052530). Theref… | 2000 |
| * | K003065 | Seednet, Model EP6T5, EP5E5Summary page 1…CryoThera®, which are cryosurgical units with argon- cooled Cryoprobes, as Class II devices (K980913, K991272, K991517, K993965, K003065, K010991, K012497, K011950, K021261, K031117, K042667, K051052, K052530). Therefore, cryo… | 2000 |
| * | K010991 | Seednet, Models FP6T5, FP5T5, FP5T3Summary page 1…a®, which are cryosurgical units with argon- cooled Cryoprobes, as Class II devices (K980913, K991272, K991517, K993965, K003065, K010991, K012497, K011950, K021261, K031117, K042667, K051052, K052530). Therefore, cryosurgical… | 2001 |
| * | K012497 | Cryo-Hit, Models EP6T5, FP5T5, FP5T3, EP2T2, EP1T1, and EP2T1Summary page 1…its with argon- cooled Cryoprobes, as Class II devices (K980913, K991272, K991517, K993965, K003065, K010991, K012497, K011950, K021261, K031117, K042667, K051052, K052530). Therefore, cryosurgical units with… | 2001 |
| * | K011950 | Seednet, Model FP6T5, FP5T5, FP5T3Summary page 1…argon- cooled Cryoprobes, as Class II devices (K980913, K991272, K991517, K993965, K003065, K010991, K012497, K011950, K021261, K031117, K042667, K051052, K052530). Therefore, cryosurgical units with argon-c… | 2002 |
| * | K021261 | Seednet System and Seednetgold System, Models GP6T5, GP5T5, GP5T3, HP5T5 & HP5T3Summary page 1…cooled Cryoprobes, as Class II devices (K980913, K991272, K991517, K993965, K003065, K010991, K012497, K011950, K021261, K031117, K042667, K051052, K052530). Therefore, cryosurgical units with argon-cooled pro… | 2002 |
| * | K031117 | Seednet System and Seednetgold SystemSummary page 1…cooled Cryoprobes, as Class II devices (K980913, K991272, K991517, K993965, K003065, K010991, K012497, K011950, K021261, K031117, K042667, K051052, K052530). Therefore, cryosurgical units with argon-cooled probes are C… | 2003 |
| * | K042667 | Seednet Gold with Renal Kit, Model Fprpr 3021, (Renal Kit), Fprch 2024 (Seednetgold)Summary page 1…cooled Cryoprobes, as Class II devices (K980913, K991272, K991517, K993965, K003065, K010991, K012497, K011950, K021261, K031117, K042667, K051052, K052530). Therefore, cryosurgical units with argon-cooled probes are Class II m… | 2004 |
| * | K051052 | Seednet Family (Seednet/Seedgold System, Cryothera System, Cryo-Hit System)Summary page 1…I devices (K980913, K991272, K991517, K993965, K003065, K010991, K012497, K011950, K021261, K031117, K042667, K051052, K052530). Therefore, cryosurgical units with argon-cooled probes are Class II medical devices. Predicate De… | 2005 |
| * | K052530 | Seednet, Seednet Gold, Cryohit, CryotheraSummary page 1…(K980913, K991272, K991517, K993965, K003065, K010991, K012497, K011950, K021261, K031117, K042667, K051052, K052530). Therefore, cryosurgical units with argon-cooled probes are Class II medical devices. Predicate Devices:… | 2005 |
What descends from it? (28)
See all 284 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-0665-2021 | Under Investigation by firm | Complaint trend regarding needle shaft gas leaks. |
| Nov 18, 2020 | Class II | Z-0693-2021 | Under Investigation by firm | Complaint trend regarding needle shaft gas leaks. |
| Nov 18, 2020 | Class II | Z-0691-2021 | Under Investigation by firm | Complaint trend regarding needle shaft gas leaks. |
| Nov 18, 2020 | Class II | Z-0673-2021 | Under Investigation by firm | Complaint trend regarding needle shaft gas leaks. |
| Nov 18, 2020 | Class II | Z-0674-2021 | Under Investigation by firm | Complaint trend regarding needle shaft gas leaks. |
| Nov 18, 2020 | Class II | Z-0692-2021 | Under Investigation by firm | Complaint trend regarding needle shaft gas leaks. |
| Nov 18, 2020 | Class II | Z-0686-2021 | Under Investigation by firm | Complaint trend regarding needle shaft gas leaks. |
| Dec 20, 2010 | Not classified | Z-1031-2011 | 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 8 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 5 years and passes through 1 company; a new generation was cleared every 11 months on median.
- 5 of the 13 ancestors have a recall of any class.
- Of its descendants, K121251 (Galil Medical, Ltd., 2012) has gone furthest, with 22 descendants of its own.
- 3 other devices also cite its predicate K980913.
How does its category compare?
All GEH devicesGEH Unit, Cryosurgical, Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Presice system is intended for cryogenic destruction of tissue during surgical procedures. The Presice 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…
Read the full statement (254 words)
The Presice system is intended for cryogenic destruction of tissue during surgical procedures. The Presice 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 Presice 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, ablation of breast fibroadenomas)
* 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)
The Presice System may be used with an ultrasound device to provide real-time visualization of the cryosurgical procedure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060390 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060390: Seednet, Seednet Gold, Cryohit, Cryo Thera.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060390
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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