510(k) · Cleared
ClearedCo-Ablation System with Sterile Co-Ablation Probe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hygea Medical Technology Co., Ltd. · GEH Unit, Cryosurgical, Accessories
Cleared on Jan 29, 2025 as substantially equivalent to K201588 (Varian Medical Systems, Inc., 2020) and 2 other predicates after a 124-day review. Its family tree reaches back 13 generations to 1993.
- Decided
- Jan 29, 2025
- Review
- 124 days
- Class
- Class II
- Product code
- GEH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 13 generations to K926514 (1993). 68 ancestors in all, the oldest K790187 (1979). No later device cites it as a predicate yet.
- Root · 13 generations backK926514 Endoscopic Ultrasound System Type 20Olympus Corp. · 1993 · Recalled
- 9 generations between
- 3 generations backK153489 Cryocare CS Surgical SystemHealthtronics · 2016
- 2 generations backK201588 CRYOCARE TOUCH System and Accessories, Endocare 1.7mm Round Ice…Varian Medical Systems, Inc. · 2020
- 1 generation backK230271 ISOLIS CryoprobeVarian Medical Systems, Inc. · 2023
- This deviceK243042 Co-Ablation System with Sterile Co-Ablation ProbeHygea Medical Technology Co., Ltd. · 2025
Show all 13 generations
- Root · 13 generations backK926514 Endoscopic Ultrasound System Type 20Olympus Corp. · 1993 · Recalled
- 12 generations backK963023 Ultrasound Gastroscope GF Type UM30POlympus America, Inc. · 1997
- 11 generations backK994373 Hdi 1500/SA 8800 Ultrasound System with Multiplane Transesophageal…Atl Ultrasound, Inc. · 2000
- 10 generations backK030191 Terason Model 2000/Bas Portable Ultrasound SystemTeratech Corp. · 2003
- 9 generations backK032333 Cryocare CS Surgical SystemEndocare, Inc. · 2003
- 8 generations backK050347 Modification to Cryocare CS Surgical SystemEndocare, Inc. · 2005
- 7 generations backK060279 Cryocare CS Surgical SystemEndocare, Inc. · 2006 · Recalled
- 6 generations backK101333 Cryocare CS Surgical SystemEndocare, Inc. · 2010 · Recalled
- 5 generations backK141110 Cryocare CS Surgical SystemHealthtronics · 2015
- 4 generations backK151968 Cryocare CS-3 Surgical System version 5Healthtronics · 2015
- 3 generations backK153489 Cryocare CS Surgical SystemHealthtronics · 2016
- 2 generations backK201588 CRYOCARE TOUCH System and Accessories, Endocare 1.7mm Round Ice…Varian Medical Systems, Inc. · 2020
- 1 generation backK230271 ISOLIS CryoprobeVarian Medical Systems, Inc. · 2023
- This deviceK243042 Co-Ablation System with Sterile Co-Ablation ProbeHygea Medical Technology Co., Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K926514 | Endoscopic Ultrasound System Type 20 | Olympus Corp. | 1993 | 1 |
| −12 | K963023 | Ultrasound Gastroscope GF Type UM30P | Olympus America, Inc. | 1997 | — |
| −11 | K994373 | Hdi 1500/SA 8800 Ultrasound System with Multiplane Transesophageal Ultrasound… | Atl Ultrasound, Inc. | 2000 | — |
| −10 | K030191 | Terason Model 2000/Bas Portable Ultrasound System | Teratech Corp. | 2003 | — |
| −9 | K032333 | Cryocare CS Surgical System | Endocare, Inc. | 2003 | — |
| −8 | K050347 | Modification to Cryocare CS Surgical System | Endocare, Inc. | 2005 | — |
| −7 | K060279 | Cryocare CS Surgical System | Endocare, Inc. | 2006 | 3 |
| −6 | K101333 | Cryocare CS Surgical System | Endocare, Inc. | 2010 | 2 |
| −5 | K141110 | Cryocare CS Surgical System | Healthtronics | 2015 | — |
| −4 | K151968 | Cryocare CS-3 Surgical System version 5 | Healthtronics | 2015 | — |
| −3 | K153489 | Cryocare CS Surgical System | Healthtronics | 2016 | — |
| −2 | K201588 | CRYOCARE TOUCH System and Accessories, Endocare 1.7mm Round Ice PerCryo… | Varian Medical Systems, Inc. | 2020 | — |
| −1 | K230271 | ISOLIS Cryoprobe | Varian Medical Systems, Inc. | 2023 | — |
| 0 (this device) | K243042 | Co-Ablation System with Sterile Co-Ablation Probe | Hygea Medical Technology Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1990 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 5 | 0 |
| 1998 | 1 | 0 |
| 1999 | 4 | 0 |
| 2000 | 3 | 0 |
| 2001 | 5 | 0 |
| 2002 | 7 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2019 | 1 | 0 |
| 2024 | 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? (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 |
|---|---|---|---|
| * | K201588 | CRYOCARE TOUCH System and Accessories, Endocare 1.7mm Round Ice PerCryo Cryoprobe…Summary page 6…Cryosurgical Unit And Accessories Regulatory Class: Class II Regulatory Class: GEH 4. Predicate Device(s): CRYOCARE TOUCH™ System and Accessories (k201588) Manufacturer: Varian Medical Systems, Inc. XSense Cryoablation System with CryoProbes(K240892) Manufacturer: IceCure Medical Lt… | 2020 |
| * | K240892 | XSense Cryoablation System with CryoprobesSummary page 6…GEH 4. Predicate Device(s): CRYOCARE TOUCH™ System and Accessories (k201588) Manufacturer: Varian Medical Systems, Inc. XSense Cryoablation System with CryoProbes(K240892) Manufacturer: IceCure Medical Ltd. ISOLIS Cryoprobe(K230271) Manufacturer: Varian Medical Systems, Inc. The CRYOCARE TOUCH™ S… | 2024 |
| * | K230271 | ISOLIS CryoprobeSummary page 6…ccessories (k201588) Manufacturer: Varian Medical Systems, Inc. XSense Cryoablation System with CryoProbes(K240892) Manufacturer: IceCure Medical Ltd. ISOLIS Cryoprobe(K230271) Manufacturer: Varian Medical Systems, Inc. The CRYOCARE TOUCH™ System and accessories are a cryotherapy delivery system that i… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
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 32 years and passes through 8 companies; a new generation was cleared every 2.6 years on median.
- 21 of the 68 ancestors have a recall of any class.
- 3 other devices also cite its predicate K201588.
How does its category compare?
All GEH devicesGEH Unit, Cryosurgical, Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
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 Co-Ablation System with Sterile Co-Ablation Probe is designed to destroy solid tumors, 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 Co-Ablate tissue by the application of extreme cold temperatures including prostate and kidney tissue, liver…
Read the full statement (241 words)
The Co-Ablation System with Sterile Co-Ablation Probe is designed to destroy solid tumors, 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 Co-Ablate 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 also 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 breast fibroadenomas.
• Ablation of leukoplakia of mouth, angiomas, sebaceous hyperplasia, basal cell tumors of the eyelid or canthus area, ulcerated basal cell tumors, dermatofibromas, small hemangiomas, mucocele cysts, multiple warts, plantar warts, hemorrhoids, anal fissures, perianal condylomata, pilonidal cysts, actinic and seborrheic keratoses, cavernous hemangiomas, 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 management/cryoanalgesia.
Dermatology
• Ablation or freezing of skin cancers and other cutaneous disorders.
Proctology
• Ablation of benign or malignant growths of the anus and rectum.
• Ablation of hemorrhoids.
Thoracic Surgery
• Ablation of cancerous lesions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243042 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243042: Co-Ablation System with Sterile Co-Ablation Probe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243042
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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