510(k) · Cleared
ClearedModification to Cryocare CS Surgical 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 Feb 25, 2005 as substantially equivalent to K032333 (Endocare, Inc., 2003) and 1 other predicate after a 14-day review. Its family tree reaches back 5 generations to 1993. 12 later devices descend from it.
- Decided
- Feb 25, 2005
- Review
- 14 days
- Class
- Class II
- Product code
- GEH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K926514 (1993). 16 ancestors in all, the oldest K850478 (1985). 12 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK926514 Endoscopic Ultrasound System Type 20Olympus Corp. · 1993 · Recalled
- 4 generations backK963023 Ultrasound Gastroscope GF Type UM30POlympus America, Inc. · 1997
- 3 generations backK994373 Hdi 1500/SA 8800 Ultrasound System with Multiplane Transesophageal…Atl Ultrasound, Inc. · 2000
- 2 generations backK030191 Terason Model 2000/Bas Portable Ultrasound SystemTeratech Corp. · 2003
- 1 generation backK032333 Cryocare CS Surgical SystemEndocare, Inc. · 2003
- This deviceK050347 Modification to Cryocare CS Surgical SystemEndocare, Inc. · 2005
- Descendant · cites it directly · 9 of its ownK060279 Cryocare CS Surgical SystemEndocare, Inc. · 2006 · Recalled
- Descendant · 2 generations on · 8 of its ownK101333 Cryocare CS Surgical SystemEndocare, Inc. · 2010 · Recalled
- Descendant · 3 generations on · 7 of its ownK141110 Cryocare CS Surgical SystemHealthtronics · 2015
- Descendant · 4 generations on · 6 of its ownK151968 Cryocare CS-3 Surgical System version 5Healthtronics · 2015
- Descendant · 4 generations on · 5 of its ownK153489 Cryocare CS Surgical SystemHealthtronics · 2016
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K060279Cryocare CS Surgical SystemEndocare, Inc. · 2006 · cites it directly9descendants
- K101333Cryocare CS Surgical SystemEndocare, Inc. · 2010 · 2 generations on8descendants
- K141110Cryocare CS Surgical SystemHealthtronics · 2015 · 3 generations on7descendants
- K151968Cryocare CS-3 Surgical System version 5Healthtronics · 2015 · 4 generations on6descendants
- K153489Cryocare CS Surgical SystemHealthtronics · 2016 · 4 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K926514 | Endoscopic Ultrasound System Type 20 | Olympus Corp. | 1993 | 1 |
| −4 | K963023 | Ultrasound Gastroscope GF Type UM30P | Olympus America, Inc. | 1997 | — |
| −3 | K994373 | Hdi 1500/SA 8800 Ultrasound System with Multiplane Transesophageal Ultrasound… | Atl Ultrasound, Inc. | 2000 | — |
| −2 | K030191 | Terason Model 2000/Bas Portable Ultrasound System | Teratech Corp. | 2003 | — |
| −1 | K032333 | Cryocare CS Surgical System | Endocare, Inc. | 2003 | — |
| 0 (this device) | K050347 | Modification to Cryocare CS Surgical System | Endocare, Inc. | 2005 | — |
| +1 | K060279 | Cryocare CS Surgical System | Endocare, Inc. | 2006 | 3 |
| +2 | K101333 | Cryocare CS Surgical System | Endocare, Inc. | 2010 | 2 |
| +3 | K141110 | Cryocare CS Surgical System | Healthtronics | 2015 | — |
| +4 | K151968 | Cryocare CS-3 Surgical System version 5 | Healthtronics | 2015 | — |
| +4 | K153489 | Cryocare CS Surgical System | Healthtronics | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2020 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 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? (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 |
|---|---|---|---|
| * | K032333 | Cryocare CS Surgical SystemSummary page 1…949.450.5424 949.450.5300 K032333 - Endocare Cryocare CS Surgical System PREDICATE DEVICE Decision date: 8/18/2003 K043278 - Te… | 2003 |
| * | K043278 | Teratech Model 8IOC4, 8IOL4 & 10LAP4 ProbesSummary page 1…949.450.5300 K032333 - Endocare Cryocare CS Surgical System PREDICATE DEVICE Decision date: 8/18/2003 K043278 - Teratech Model 810C4, 810L4, 1OLALP4 Probe Decision date: 12/13/2004 DEVICE The C… | 2004 |
What descends from it? (12)
See all 122 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)
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 12 years and passes through 5 companies; a new generation was cleared every 2.9 years on median.
- 4 of the 16 ancestors have a recall of any class.
- Of its descendants, K060279 (Endocare, Inc., 2006) has gone furthest, with 9 descendants of its own.
- 1 other device also cites its predicate K032333.
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 CS 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 freeze/ablate tissue by the application of extreme cold temperatures including prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts. In addition…
Read the full statement (235 words)
The Cryocare CS 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 freeze/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 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 leukoplakia 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
Gynecolowq
* 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 arrhythmic cardiac tissue
* Ablation of cancerous lesions
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050347 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050347: Modification to Cryocare CS Surgical System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050347
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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