510(k) · Cleared
ClearedEndocre 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 Apr 10, 1998 as substantially equivalent to K973190 (Cryomedical Sciences, Inc., 1997) and 1 other predicate after an 88-day review. Its family tree reaches back 3 generations to 1995. 93 later devices descend from it.
- Decided
- Apr 10, 1998
- Review
- 88 days
- Class
- Class II
- Product code
- GEH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K942299 (1995). 5 ancestors in all. 93 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK942299 Endocare Cryotherapy SystemCytocare, Inc. · 1995
- 2 generations backK963826 Endocare Crycare Cryosurgical SystemEndocare, Inc. · 1996
- 1 generation backK973686 Endocare Cryocare Cryosurgical SystemEndocare, Inc. · 1997
- This deviceK980110 Endocre Cryocare Cryosurgical SystemEndocare, Inc. · 1998
- Descendant · cites it directly · 92 of its ownK011722 Atricure Bipolar Coagulation SystemAtriCure, Inc. · 2001
- Descendant · 2 generations on · 90 of its ownK020919 Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1AtriCure, Inc. · 2002
- Descendant · 3 generations on · 42 of its ownK040690 Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and…Cryocath Technologies, Inc. · 2004
- Descendant · 3 generations on · 34 of its ownK031247 Cardioblate Bipolar Radiofrequency Surgical Ablation SystemMedtronic Vascular · 2003
- Descendant · 2 generations on · 23 of its ownK022894 Epicor Medical Ablation SystemEpicor Medical, Inc. · 2004
Showing 5 of 93 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 93 · See all- K011722Atricure Bipolar Coagulation SystemAtriCure, Inc. · 2001 · cites it directly92descendants
- K020919Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1AtriCure, Inc. · 2002 · 2 generations on90descendants
- K040690Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and Cryosurgical ConsoleCryocath Technologies, Inc. · 2004 · 3 generations on42descendants
- K031247Cardioblate Bipolar Radiofrequency Surgical Ablation SystemMedtronic Vascular · 2003 · 3 generations on34descendants
- K022894Epicor Medical Ablation SystemEpicor Medical, Inc. · 2004 · 2 generations on23descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K942299 | Endocare Cryotherapy System | Cytocare, Inc. | 1995 | — |
| −2 | K963826 | Endocare Crycare Cryosurgical System | Endocare, Inc. | 1996 | — |
| −1 | K973686 | Endocare Cryocare Cryosurgical System | Endocare, Inc. | 1997 | — |
| 0 (this device) | K980110 | Endocre Cryocare Cryosurgical System | Endocare, Inc. | 1998 | — |
| +1 | K011722 | Atricure Bipolar Coagulation System | AtriCure, Inc. | 2001 | — |
| +2 | K020919 | Atricure Bipolar System, Models ASU1, ASU2, ASU3, LHP1, LHP2, RHP1 | AtriCure, Inc. | 2002 | — |
| +3 | K040690 | Surgifrost 10 CM Cryosurgical Device Plus Frostbyte Clamp and Cryosurgical… | Cryocath Technologies, Inc. | 2004 | — |
| +3 | K031247 | Cardioblate Bipolar Radiofrequency Surgical Ablation System | Medtronic Vascular | 2003 | — |
| +2 | K022894 | Epicor Medical Ablation System | Epicor Medical, Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K973190 | Accuprobe 450, Accuprobe 550/530 and the Accuprobe 600 SeriesSummary page 2…al System is substantially equivalent to the Cryomedical Sciences, Inc. AccuProbe® models which were found to be substantially equivalent on November 21, 1997 (reference K973 190) and the ENDOcarc cryosurgical system which was determined to be substantially equivalent on December 22, 1997 (K973686). Steril… | 1997 |
| * | K973686 | Endocare Cryocare Cryosurgical SystemSummary page 2…ially equivalent on November 21, 1997 (reference K973 190) and the ENDOcarc cryosurgical system which was determined to be substantially equivalent on December 22, 1997 (K973686). Sterilization Methodology The following sterilization information is applicable to the CRYOprobes™ only. Sterilization valida… | 1997 |
What descends from it? (93)
See all 931 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K011722 | Atricure Bipolar Coagulation System | 2001 | 92 |
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 3 years and passes through 2 companies; a new generation was cleared every 1.0 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K011722 (AtriCure, Inc., 2001) has gone furthest, with 92 descendants of its own.
- 5 other devices also cite its predicate K973190.
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 ta destroy tissue by the application of extreme cold temperatures including, prostate, and kidney tissue, liver metastases, tumors, skin lesions, and warts. In addition, the system is intcnded for use in the following indications: Urology Ablation of…
Read the full statement (200 words)
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 ta destroy tissue by the application of extreme cold temperatures including, prostate, and kidney tissue, liver metastases, tumors, skin lesions, and warts. In addition, the system is intcnded for use in the following indications:
Urology
Ablation of prostate tissue in cases of prostate cancer and benign prostatic hyperplasia
Oncology
Ablation of cancerous or malignant tissue
Ablation of benign tumors
Palliative intervention
Dermatology
Ablation or freezing of skin cancers and other cutaneous disorders
Gynecology
Ablation of malignant neoplasia or benign dysplasia of the female geniralia
General Surgery
Destruction of warts or lesions
Palliation of tumors of the oral cavity, rectum and skin
Ablation of leukoplakia of the mouth, angiomas, sebaceous hyperplasia, basal cell tumors of the eyelid or canthus arca, ulcerated basal cell tumors, dermatofibromas, small hemanglomas, mucocele cysts, multiple warts, plantar warts, hemorrhoids, anal fissures, perianal condylomata, pilonidal cysts, actinic and seborrheic keratoses, cavernous hemanglomas, recurrent cancerous lesions
Thoracic Surgery
Ablation of arrhythmic cardiac tissue
Ablation of cancerous lesions
Proctology
Ablation of benign or malignant growths of the anus or rcctum
Ablation of hemorrhoids
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/K980110 · printed Nov 6, 2026
Cite this page
510(k) Report. “K980110: Endocre 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/K980110
Report an extraction error
Are you the manufacturer?
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