510(k) · Cleared
Recalled · Class II · 2012Cryocare 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 Jun 14, 2010 as substantially equivalent to K060279 (Endocare, Inc., 2006) and 1 other predicate after a 33-day review. Its family tree reaches back 7 generations to 1993. 8 later devices descend from it. It has been recalled 2 times.
- Decided
- Jun 14, 2010
- Review
- 33 days
- Class
- Class II
- Product code
- GEH
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 7 generations to K926514 (1993). 18 ancestors in all, the oldest K850478 (1985). 8 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK926514 Endoscopic Ultrasound System Type 20Olympus Corp. · 1993 · Recalled
- 6 generations backK963023 Ultrasound Gastroscope GF Type UM30POlympus America, Inc. · 1997
- 5 generations backK994373 Hdi 1500/SA 8800 Ultrasound System with Multiplane Transesophageal…Atl Ultrasound, Inc. · 2000
- 4 generations backK030191 Terason Model 2000/Bas Portable Ultrasound SystemTeratech Corp. · 2003
- 3 generations backK032333 Cryocare CS Surgical SystemEndocare, Inc. · 2003
- 2 generations backK050347 Modification to Cryocare CS Surgical SystemEndocare, Inc. · 2005
- 1 generation backK060279 Cryocare CS Surgical SystemEndocare, Inc. · 2006 · Recalled
- This deviceK101333 Cryocare CS Surgical SystemEndocare, Inc. · 2010
- Descendant · cites it directly · 7 of its ownK141110 Cryocare CS Surgical SystemHealthtronics · 2015
- Descendant · 2 generations on · 6 of its ownK151968 Cryocare CS-3 Surgical System version 5Healthtronics · 2015
- Descendant · 2 generations on · 5 of its ownK153489 Cryocare CS Surgical SystemHealthtronics · 2016
- Descendant · 3 generations on · 4 of its ownK201588 CRYOCARE TOUCH System and Accessories, Endocare 1.7mm Round Ice…Varian Medical Systems, Inc. · 2020
- Descendant · 4 generations on · 1 of its ownK230271 ISOLIS CryoprobeVarian Medical Systems, Inc. · 2023
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K141110Cryocare CS Surgical SystemHealthtronics · 2015 · cites it directly7descendants
- K151968Cryocare CS-3 Surgical System version 5Healthtronics · 2015 · 2 generations on6descendants
- K153489Cryocare CS Surgical SystemHealthtronics · 2016 · 2 generations on5descendants
- K201588CRYOCARE TOUCH System and Accessories, Endocare 1.7mm Round Ice PerCryo Cryoprobe…Varian Medical Systems, Inc. · 2020 · 3 generations on4descendants
- K230271ISOLIS CryoprobeVarian Medical Systems, Inc. · 2023 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K926514 | Endoscopic Ultrasound System Type 20 | Olympus Corp. | 1993 | 1 |
| −6 | K963023 | Ultrasound Gastroscope GF Type UM30P | Olympus America, Inc. | 1997 | — |
| −5 | K994373 | Hdi 1500/SA 8800 Ultrasound System with Multiplane Transesophageal Ultrasound… | Atl Ultrasound, Inc. | 2000 | — |
| −4 | K030191 | Terason Model 2000/Bas Portable Ultrasound System | Teratech Corp. | 2003 | — |
| −3 | K032333 | Cryocare CS Surgical System | Endocare, Inc. | 2003 | — |
| −2 | K050347 | Modification to Cryocare CS Surgical System | Endocare, Inc. | 2005 | — |
| −1 | K060279 | Cryocare CS Surgical System | Endocare, Inc. | 2006 | 3 |
| 0 (this device) | K101333 | Cryocare CS Surgical System | Endocare, Inc. | 2010 | — |
| +1 | K141110 | Cryocare CS Surgical System | Healthtronics | 2015 | — |
| +2 | K151968 | Cryocare CS-3 Surgical System version 5 | Healthtronics | 2015 | — |
| +2 | K153489 | Cryocare CS Surgical System | Healthtronics | 2016 | — |
| +3 | K201588 | CRYOCARE TOUCH System and Accessories, Endocare 1.7mm Round Ice PerCryo… | Varian Medical Systems, Inc. | 2020 | — |
| +4 | K230271 | ISOLIS Cryoprobe | Varian Medical Systems, Inc. | 2023 | — |
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 |
|---|---|---|
| 2015 | 2 | 0 |
| 2016 | 1 | 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 |
|---|---|---|---|
| * | K060279 | Cryocare CS Surgical SystemSummary page 1…, TX 78717 Contact: Cheryl Blake 949-285-3517 e-mail: cherylblakecgcox.net K060279 - Endocare Cryocare CS Surgical System PREDICATE Decision date: February 26, 2006 DEVICE DEVICE The C… | 2006 |
| * | K043278 | Teratech Model 8IOC4, 8IOL4 & 10LAP4 ProbesSummary page 3…te devices: EQUIVALENCE * Has the same intended use; * The 1OLAP4 ultrasound probe is the same as Teratech's cleared under K043278and is intended for the same clinical application; * Uses the same operating principle and… | 2004 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141110 | Cryocare CS Surgical System | 2015 | 7 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 20, 2012 | Class II | Z-0825-2013 | Incorrect or no expiration date | The Endocare 3.8mm RenalCryo Cryoprobe is being recalled because the label on the outer box has the incorrect expiration date. |
| Feb 27, 2012 | Not classified | Z-1275-2012 | Labeling mix-ups | HealthTronics has initiated this recall of these products because there have been instances where the temperature probes (aka TempProbes) in the kit may be mislabeled. In some instances, the label near the prove does not match the label… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 5 companies; a new generation was cleared every 2.9 years on median.
- 5 of the 18 ancestors have a recall of any class.
- Of its descendants, K141110 (Healthtronics, 2015) has gone furthest, with 7 descendants of its own.
How does its category compare?
All GEH devicesGEH Unit, Cryosurgical, Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 Oryocare CS Surgical System is intended for use in open, minimally invasive or endloscopic 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 wadts. In addition…
Read the full statement (230 words)
The Oryocare CS Surgical System is intended for use in open, minimally invasive or endloscopic 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 wadts.
In addition, the system is intended for use in the following indications:
General Surger
* 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 hemnanglomnas, mucocele cysts, multiple warts, plantar warts, hemorrhoids, anal fissures, perianal condylomnata, pilonidal cysts, actinic and seborrheic keratoses, cavernous hemanglomnas, 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/crycanalgesia
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 Sur-ger
* Ablation of arrhythmic cardiac tissue
* Ablation of cancerous lesions
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101333 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101333: 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/K101333
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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