510(k) · Cleared
ClearedCryo-Hit Model Numbers EP3T3, EP5T2, EP5T5, EP7T5, EP8T5
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Galil Medical, Ltd. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Jul 1, 1998 after a 113-day review. The FDA summary names its predicate without a number. 153 later devices descend from it.
- Decided
- Jul 1, 1998
- Review
- 113 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 0
153 later devices descend from it, 4 citing it directly.
- This deviceK980913 Cryo-Hit Model Numbers EP3T3, EP5T2, EP5T5, EP7T5, EP8T5Galil Medical, Ltd. · 1998
- Descendant · cites it directly · 125 of its ownK991517 Cryo-Hit II, Models EP3T3, EP5T2, EP5T5, EP7T5, EP8T5Galil Medical, Ltd. · 1999
- Descendant · 2 generations on · 123 of its ownK993965 Cryo-HitGalil Medical, Ltd. · 2000
- Descendant · 2 generations on · 92 of its ownK011722 Atricure Bipolar Coagulation SystemAtriCure, Inc. · 2001
- Descendant · 3 generations on · 90 of its ownK020919 Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1AtriCure, Inc. · 2002
- Descendant · 4 generations on · 42 of its ownK040690 Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and…Cryocath Technologies, Inc. · 2004
Showing 5 of 153 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 153 · See all- K991517Cryo-Hit II, Models EP3T3, EP5T2, EP5T5, EP7T5, EP8T5Galil Medical, Ltd. · 1999 · cites it directly125descendants
- K993965Cryo-HitGalil Medical, Ltd. · 2000 · 2 generations on123descendants
- K011722Atricure Bipolar Coagulation SystemAtriCure, Inc. · 2001 · 2 generations on92descendants
- K020919Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1AtriCure, Inc. · 2002 · 3 generations on90descendants
- K040690Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and Cryosurgical ConsoleCryocath Technologies, Inc. · 2004 · 4 generations on42descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K980913 | Cryo-Hit Model Numbers EP3T3, EP5T2, EP5T5, EP7T5, EP8T5 | Galil Medical, Ltd. | 1998 | — |
| +1 | K991517 | Cryo-Hit II, Models EP3T3, EP5T2, EP5T5, EP7T5, EP8T5 | Galil Medical, Ltd. | 1999 | — |
| +2 | K993965 | Cryo-Hit | Galil Medical, Ltd. | 2000 | — |
| +2 | K011722 | Atricure Bipolar Coagulation System | AtriCure, Inc. | 2001 | — |
| +3 | K020919 | Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1 | AtriCure, Inc. | 2002 | — |
| +4 | K040690 | Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and Cryosurgical… | Cryocath Technologies, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 11 | 0 |
| 2007 | 5 | 0 |
| 2008 | 10 | 0 |
| 2009 | 4 | 0 |
| 2010 | 4 | 0 |
| 2011 | 4 | 0 |
| 2012 | 9 | 0 |
| 2013 | 3 | 0 |
| 2014 | 8 | 0 |
| 2015 | 6 | 0 |
| 2016 | 8 | 0 |
| 2017 | 7 | 0 |
| 2018 | 8 | 0 |
| 2019 | 10 | 0 |
| 2020 | 7 | 0 |
| 2021 | 4 | 0 |
| 2022 | 6 | 0 |
| 2023 | 6 | 0 |
| 2024 | 10 | 0 |
| 2025 | 4 | 0 |
| 2026 | 6 | 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 GEI? 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 GEI device
- #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 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 |
|---|---|---|---|
| * | — | CRYOcare - ENDOcare Named without a submission number | |
| * | — | CMS AccuProbe System Named without a submission number |
What descends from it? (153)
See all 1534 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K991517 (Galil Medical, Ltd., 1999) has gone furthest, with 125 descendants of its own.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GEI
52in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEI
113in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEI
4in 2025
Class I (14 since 2007) Class II/III not classified
Adverse event reports per year · GEI
7,592in 2025
MAUDE reports naming product code GEI, 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 | 50 | 51 | 21 | 2,795 |
| 2008 | 61 | 71 | 19 | 2,556 |
| 2009 | 42 | 130 | 27 | 3,591 |
| 2010 | 46 | 109 | 51 | 3,377 |
| 2011 | 35 | 135 | 32 | 4,463 |
| 2012 | 39 | 133 | 30 | 5,216 |
| 2013 | 48 | 136 | 13 | 4,897 |
| 2014 | 49 | 103 | 3 | 4,908 |
| 2015 | 47 | 123 | 4 | 4,936 |
| 2016 | 64 | 108 | 3 | 5,616 |
| 2017 | 52 | 72 | 2 | 6,073 |
| 2018 | 47 | 93 | 6 | 6,545 |
| 2019 | 48 | 93 | 5 | 7,067 |
| 2020 | 59 | 105 | 1 | 6,490 |
| 2021 | 46 | 146 | 6 | 6,354 |
| 2022 | 55 | 150 | 49 | 6,103 |
| 2023 | 65 | 104 | 27 (4) | 7,176 |
| 2024 | 59 | 125 | 22 (10) | 7,897 |
| 2025 | 52 | 113 | 4 | 7,592 |
| 2026 | 43 | 183 | 8 | — |
What is it indicated for?
CRYO-HIT™ 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, neurosurgery, thoracic surgery, ENT, gynecology, oncology, proctology, and urology for the ablation of tissue, ihcluding liver metastases, skin lesions, warts, and prostate tissue.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K980913 · printed Nov 4, 2026
Cite this page
510(k) Report. “K980913: Cryo-Hit Model Numbers EP3T3, EP5T2, EP5T5, EP7T5, EP8T5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980913
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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