510(k) · Cleared
ClearedCryoThin™ Surgical System and Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medinux (Tianjin) Technologies Co., Ltd. · GEH Unit, Cryosurgical, Accessories
Cleared on Nov 27, 2023 as substantially equivalent to K201588 (Varian Medical Systems, Inc., 2020) and 1 other predicate after a 173-day review. Its family tree reaches back 12 generations to 1993.
- Decided
- Nov 27, 2023
- Review
- 173 days
- Class
- Class II
- Product code
- GEH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K926514 (1993). 48 ancestors in all, the oldest K850478 (1985). No later device cites it as a predicate yet.
- Root · 12 generations backK926514 Endoscopic Ultrasound System Type 20Olympus Corp. · 1993 · Recalled
- 8 generations between
- 3 generations backK151968 Cryocare CS-3 Surgical System version 5Healthtronics · 2015
- 2 generations backK153489 Cryocare CS Surgical SystemHealthtronics · 2016
- 1 generation backK201588 CRYOCARE TOUCH System and Accessories, Endocare 1.7mm Round Ice…Varian Medical Systems, Inc. · 2020
- This deviceK231661 CryoThin™ Surgical System and AccessoriesMedinux (Tianjin) Technologies Co., Ltd. · 2023
Show all 12 generations
- Root · 12 generations backK926514 Endoscopic Ultrasound System Type 20Olympus Corp. · 1993 · Recalled
- 11 generations backK963023 Ultrasound Gastroscope GF Type UM30POlympus America, Inc. · 1997
- 10 generations backK994373 Hdi 1500/SA 8800 Ultrasound System with Multiplane Transesophageal…Atl Ultrasound, Inc. · 2000
- 9 generations backK030191 Terason Model 2000/Bas Portable Ultrasound SystemTeratech Corp. · 2003
- 8 generations backK032333 Cryocare CS Surgical SystemEndocare, Inc. · 2003
- 7 generations backK050347 Modification to Cryocare CS Surgical SystemEndocare, Inc. · 2005
- 6 generations backK060279 Cryocare CS Surgical SystemEndocare, Inc. · 2006 · Recalled
- 5 generations backK101333 Cryocare CS Surgical SystemEndocare, Inc. · 2010 · Recalled
- 4 generations backK141110 Cryocare CS Surgical SystemHealthtronics · 2015
- 3 generations backK151968 Cryocare CS-3 Surgical System version 5Healthtronics · 2015
- 2 generations backK153489 Cryocare CS Surgical SystemHealthtronics · 2016
- 1 generation backK201588 CRYOCARE TOUCH System and Accessories, Endocare 1.7mm Round Ice…Varian Medical Systems, Inc. · 2020
- This deviceK231661 CryoThin™ Surgical System and AccessoriesMedinux (Tianjin) Technologies Co., Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K926514 | Endoscopic Ultrasound System Type 20 | Olympus Corp. | 1993 | 1 |
| −11 | K963023 | Ultrasound Gastroscope GF Type UM30P | Olympus America, Inc. | 1997 | — |
| −10 | K994373 | Hdi 1500/SA 8800 Ultrasound System with Multiplane Transesophageal Ultrasound… | Atl Ultrasound, Inc. | 2000 | — |
| −9 | K030191 | Terason Model 2000/Bas Portable Ultrasound System | Teratech Corp. | 2003 | — |
| −8 | K032333 | Cryocare CS Surgical System | Endocare, Inc. | 2003 | — |
| −7 | K050347 | Modification to Cryocare CS Surgical System | Endocare, Inc. | 2005 | — |
| −6 | K060279 | Cryocare CS Surgical System | Endocare, Inc. | 2006 | 3 |
| −5 | K101333 | Cryocare CS Surgical System | Endocare, Inc. | 2010 | 2 |
| −4 | K141110 | Cryocare CS Surgical System | Healthtronics | 2015 | — |
| −3 | K151968 | Cryocare CS-3 Surgical System version 5 | Healthtronics | 2015 | — |
| −2 | K153489 | Cryocare CS Surgical System | Healthtronics | 2016 | — |
| −1 | K201588 | CRYOCARE TOUCH System and Accessories, Endocare 1.7mm Round Ice PerCryo… | Varian Medical Systems, Inc. | 2020 | — |
| 0 (this device) | K231661 | CryoThin™ Surgical System and Accessories | Medinux (Tianjin) Technologies Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 4 | 0 |
| 2000 | 3 | 0 |
| 2001 | 4 | 0 |
| 2002 | 4 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 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? (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 |
|---|---|---|---|
| * | K201588 | CRYOCARE TOUCH System and Accessories, Endocare 1.7mm Round Ice PerCryo Cryoprobe…Summary page 6…Cryosurgical unit and accessories Regulation Class: Class II Product Code: GEH Predicate Devices / CRYOCARE TOUCH System and Accessories (K201588) Reference 510(k): Visual-ICE® Cryoablation System (K143564) Date of Preparation: November 23, 2023 Device Desc… | 2020 |
| * | K143564 | Visual-ICE Cryoablation System, Software Revision 1.3.1Summary page 6…II Product Code: GEH Predicate Devices / CRYOCARE TOUCH System and Accessories (K201588) Reference 510(k): Visual-ICE® Cryoablation System (K143564) Date of Preparation: November 23, 2023 Device Description: Cryosurgery is the use of ultra-low temperatures for selecti… | 2015 |
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 30 years and passes through 8 companies; a new generation was cleared every 3.1 years on median.
- 19 of the 48 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. 2023, 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 CryoThin Surgical System is intended for cryosurgery in the fields of general surgery, urology, gynecology, oncology, neurology, dermatology, ENT, proctology, pulmonary surgery and thoracic surgery. The system is designed to freeze/ablate tissue by the application of extreme cold temperatures including prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts. The system has the following specific indications: General Surgery •…
Read the full statement (220 words)
The CryoThin Surgical System is intended for cryosurgery in the fields of general surgery, urology, gynecology, oncology, neurology, dermatology, ENT, proctology, pulmonary surgery and thoracic surgery. The system is designed to
freeze/ablate tissue by the application of extreme cold temperatures including prostate and kidney tissue, liver metastases,
tumors, skin lesions, and warts. The system has the following specific 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 the 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 or rectum
• Ablation of hemorrhoids
Thoracic Surgery
• Ablation of cancerous lesions
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231661 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231661: CryoThin™ Surgical System and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231661
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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