510(k) · Cleared
Recalled · 2008Cryocare Surgical System, Model Cryo 20
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 5, 2002 as substantially equivalent to K011074 (Endocare, Inc., 2002) after a 27-day review. Its family tree reaches back 1 generation to 2002. 54 later devices descend from it. It has been recalled 2 times.
- Decided
- Dec 5, 2002
- Review
- 27 days
- Class
- Class II
- Product code
- GEH
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K011074 (2002). 54 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK011074 Cryocare Surgical SystemEndocare, Inc. · 2002 · Recalled
- This deviceK023757 Cryocare Surgical System, Model Cryo 20Endocare, Inc. · 2002
- Descendant · cites it directly · 39 of its ownK100744 Certus 140 Microwave Ablation System and Accessories, Model Certus 140Neuwave Medical, Inc. · 2010
- Descendant · 2 generations on · 38 of its ownK113237 Certus 140 2.45GHZ Ablation SystemNeuwave Medical, Inc. · 2012
- Descendant · 3 generations on · 29 of its ownK133821 Emprint Ablation SystemCovidien, LLC · 2014 · Recalled
- Descendant · 4 generations on · 13 of its ownK163105 Emprint Ablation SystemCovidien, LLC · 2016 · Recalled
- Descendant · cites it directly · 13 of its ownK032333 Cryocare CS Surgical SystemEndocare, Inc. · 2003
Showing 5 of 54 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 54 · See all- K100744Certus 140 Microwave Ablation System and Accessories, Model Certus 140Neuwave Medical, Inc. · 2010 · cites it directly39descendants
- K113237Certus 140 2.45GHZ Ablation SystemNeuwave Medical, Inc. · 2012 · 2 generations on38descendants
- K133821Emprint Ablation SystemCovidien, LLC · 2014 · 3 generations on29descendants
- K163105Emprint Ablation SystemCovidien, LLC · 2016 · 4 generations on13descendants
- K032333Cryocare CS Surgical SystemEndocare, Inc. · 2003 · cites it directly13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K011074 | Cryocare Surgical System | Endocare, Inc. | 2002 | 2 |
| 0 (this device) | K023757 | Cryocare Surgical System, Model Cryo 20 | Endocare, Inc. | 2002 | — |
| +1 | K100744 | Certus 140 Microwave Ablation System and Accessories, Model Certus 140 | Neuwave Medical, Inc. | 2010 | — |
| +2 | K113237 | Certus 140 2.45GHZ Ablation System | Neuwave Medical, Inc. | 2012 | — |
| +3 | K133821 | Emprint Ablation System | Covidien, LLC | 2014 | 7 |
| +4 | K163105 | Emprint Ablation System | Covidien, LLC | 2016 | 3 |
| +1 | K032333 | Cryocare CS Surgical System | Endocare, Inc. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 4 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 7 | 0 |
| 2021 | 3 | 0 |
| 2022 | 1 | 0 |
| 2023 | 8 | 0 |
| 2024 | 7 | 0 |
| 2025 | 4 | 0 |
| 2026 | 2 | 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? (1)
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 |
|---|---|---|---|
| * | K011074 | Cryocare Surgical System | 2002 |
What descends from it? (54)
See all 542 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 |
|---|---|---|---|---|
| Dec 5, 2008 | Not classified | Z-1401-2010 | Other | Endocare received a report of a patient death that occurred during a prostate cryoablation procedure. An autopsy attributed the cause of death to an air embolism. The safety notice for the cryoprobes was issued to refocus attention on the… |
| Dec 5, 2008 | Not classified | Z-1400-2010 | Other | Endocare received a report of a patient death that occurred during a prostate cryoablation procedure. An autopsy attributed the cause of death to an air embolism. The safety notice for the cryoprobes was issued to refocus attention on the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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 Cryocare Surgical System is intended for use in open, minimally invasive or endoscopic surgical procedures in the areas in general surgery, urology, gynecology, oncology, neurology, dermatology, ENT, proctology, pulmonary surgery and thoracic surgery. The system is designed to freezeiablate tissue by the application of extreme cold temperatures including prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts. In addition the…
Read the full statement (220 words)
The Cryocare Surgical System is intended for use in open, minimally invasive or endoscopic surgical procedures in the areas in general surgery, urology, gynecology, oncology, neurology, dermatology, ENT, proctology, pulmonary surgery and thoracic surgery. The system is designed to freezeiablate 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 intended: for use in the following indications:
General Surgery
Destruction of warts or lesions
Palliation of tumors of the oral cavity, rectum and skin
Ablation of leukoplaha of the mouth, 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, hemorrhoids, anal fissures, perianal condylomata, pilonidal cysts, actinic and seborrheic keratoses, cavernous hemanglomas, recurrent cancerous lesions
Urology
Ablation of prostate tissue in cases of prostate cancer and benign prostatic hyperplasia
Gynecology
Ablation of malignant neoplasia or benign dysplasia of the female genitalia
Oncology
Ablation of cancerous or malignant tissue
Ablation of benign tumors
Palliative intervention
Neurology
Freezing of nerve tissue in pain managementlcryoanalgesia
Dermatology
Ablation or freezing of skin cancers and other cutaneous disorders
Proctology
Ablation of benign or malignant growths of the anus or rectum
Ablation of hemorrhoids
Thoracic SurPery
Ablation of arrhythmic cardiac tissue
Ablation of cancerous lesions
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/K023757 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023757: Cryocare Surgical System, Model Cryo 20.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023757
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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