510(k) · Cleared
ClearedEndocare Cryocare Cryosurgical System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Endocare, Inc. · GEH Unit, Cryosurgical, Accessories
Cleared on Dec 22, 1997 as substantially equivalent to K942299 (Cytocare, Inc., 1995) and 2 other predicates after an 87-day review. Its family tree reaches back 2 generations to 1995. 94 later devices descend from it.
- Decided
- Dec 22, 1997
- Review
- 87 days
- Class
- Class II
- Product code
- GEH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K942299 (1995). 3 ancestors in all. 94 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK942299 Endocare Cryotherapy SystemCytocare, Inc. · 1995
- 1 generation backK963826 Endocare Crycare Cryosurgical SystemEndocare, Inc. · 1996
- This deviceK973686 Endocare Cryocare Cryosurgical SystemEndocare, Inc. · 1997
- Descendant · cites it directly · 93 of its ownK980110 Endocre Cryocare Cryosurgical SystemEndocare, Inc. · 1998
- 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
- Descendant · 4 generations on · 34 of its ownK031247 Cardioblate Bipolar Radiofrequency Surgical Ablation SystemMedtronic Vascular · 2003
Showing 5 of 94 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 94 · See all- K980110Endocre Cryocare Cryosurgical SystemEndocare, Inc. · 1998 · cites it directly93descendants
- 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
- K031247Cardioblate Bipolar Radiofrequency Surgical Ablation SystemMedtronic Vascular · 2003 · 4 generations on34descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K942299 | Endocare Cryotherapy System | Cytocare, Inc. | 1995 | — |
| −1 | K963826 | Endocare Crycare Cryosurgical System | Endocare, Inc. | 1996 | — |
| 0 (this device) | K973686 | Endocare Cryocare Cryosurgical System | Endocare, Inc. | 1997 | — |
| +1 | K980110 | Endocre Cryocare Cryosurgical System | Endocare, Inc. | 1998 | — |
| +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 | — |
| +4 | K031247 | Cardioblate Bipolar Radiofrequency Surgical Ablation System | Medtronic Vascular | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 10 | 0 |
| 2007 | 4 | 0 |
| 2008 | 10 | 0 |
| 2009 | 3 | 0 |
| 2010 | 3 | 0 |
| 2011 | 4 | 0 |
| 2012 | 7 | 0 |
| 2013 | 2 | 0 |
| 2014 | 5 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 5 | 0 |
| 2019 | 8 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 6 | 0 |
| 2025 | 2 | 0 |
| 2026 | 4 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K942299 | Endocare Cryotherapy SystemSummary page 1…ntisl Equivalence The ENDOcare CRYOcare™ CRYOsurgical System is substantially equivalent to the ENDOcare 8-probe system which was cleared on January 19, 1995 (reference K942299) and the 2 and S-probe system which was cleared on December 18, 1996 (reference K963826). The ENDOcare system is also substantial… | 1995 |
| * | K963826 | Endocare Crycare Cryosurgical SystemSummary page 1…t to the ENDOcare 8-probe system which was cleared on January 19, 1995 (reference K942299) and the 2 and S-probe system which was cleared on December 18, 1996 (reference K963826). The ENDOcare system is also substantially equivalent to the Urosprobe System Model 1000 which was cleared on April 1, 1996 (ref… | 1996 |
| * | K960387 | Urosprobe System, Model 1000Summary page 1…ember 18, 1996 (reference K963826). The ENDOcare system is also substantially equivalent to the Urosprobe System Model 1000 which was cleared on April 1, 1996 (reference K960387). Sterilization Methodology The following sterilization information is applicable to the CRYOprobes™ only. Sterilization valida… | 1996 |
What descends from it? (94)
See all 941 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K980110 | Endocre Cryocare Cryosurgical System | 1998 | 93 |
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?
- The line of descent spans 2 years and passes through 2 companies; a new generation was cleared every 1.9 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K980110 (Endocare, Inc., 1998) has gone furthest, with 93 descendants of its own.
- 1 other device also cites its predicate K942299.
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 ENDOcare CRYOcare™ Cryosurgical System is intended for use in general surgery, urology, gynecology, oncology, neurology, thoracic surgery, dermatology, ENT, and proctology. The system is designed to destroy tissue by the application of extreme cold temperatures including prostate, kidney, and breast tissue, liver metastases, tumors, skin lesions, and warts.
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/K973686 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973686: Endocare Cryocare Cryosurgical System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973686
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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