Data / Medical devices / United States / Varian Medical Systems, Inc
Varian Medical Systems, Inc: FDA-registered device maker in Austin, TX, United States, 17 510(k) clearances
Varian Medical Systems, Inc is registered with the FDA (registration 3008262715) in Austin, TX, United States. It lists 9 device types. The FDA files 17 510(k) clearances under its listings, the newest dated January 17, 2025. 5 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3008262715
- Address
- 9825 Spectrum Drive, Building 2, Austin, TX, United States, 78717
- Owner or operator
- Varian Medical Systems, Inc (2914292)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- January 6, 2020
- Registered through
- 2027
- Brand names listed
- CRYOCARE TOUCH System and Accessories, Cryocare CS Basic System (CRYO-CS-3 BASIC), Cryocare CS Surgical System, Cryocare SLTM Surgical System, Cryoprobe PERC 2.4MM Slimline (PCS-24), Cryoprobe PERC 2.4MM Slimline Long (PCS-24L), Cryoprobe Renal 1.7MM Slimline (RS-17), Cryoprobe Renal 1.7MM Slimline Long (RS-17L) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia | NOY | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Agents, Embolic, For Treatment Of Uterine Fibroids | NAJ | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Device, Vascular, For Promoting Embolization | KRD | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Instrument, Biopsy | KNW | 2 | Manufacturer | accessdata.fda.gov |
| Plate, Fixation, Bone | HRS | 2 | Repackager or relabeler | accessdata.fda.gov |
| Screw, Fixation, Bone | HWC | 2 | Repackager or relabeler | accessdata.fda.gov |
| Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue | OCL | 2 | Manufacturer | accessdata.fda.gov |
| System, Ablation, Microwave And Accessories | NEY | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Unit, Cryosurgical, Accessories | GEH | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 17, 2025 | K242608 | Embozene Color-Advanced Microspheres | KRD | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| October 16, 2024 | K242794 | ONCOZENE Microspheres | KRD | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| July 19, 2024 | K240480 | IntelliBlate Microwave Ablation System Console (IB-CON); IntelliBlate Microwave Ablation System Mobile Cart (IB-CART); IntelliBlate Ximitry Probe Assembly, 13G x 15cm (IB-XPA-1315); IntelliBlate Ximitry Probe Assembly, 13G x 20cm (IB-XPA-1320); IntelliBlate Ximitry Probe Assembly, 13G x 27cm (IB-XPA-1327) | NEY | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| May 29, 2024 | K240784 | Temperature Sensor Probe (ABL-18TP20) | NEY | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| June 16, 2023 | K230015 | OmniBone Bone Marrow Biopsy Kit with Power Driver, OmniBone Bone Biopsy Kit with Power Driver | KNW | Substantially Equivalent | Laurane Medical Sas | accessdata.fda.gov |
| March 28, 2023 | K230271 | ISOLIS Cryoprobe | GEH | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| January 5, 2022 | K211149 | Urethral Warming Catheter Kit | GEH | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| August 11, 2020 | K201588 | CRYOCARE TOUCH System and Accessories, Endocare 1.7mm Round Ice PerCryo Cryoprobe, Short, Round Ice | GEH | Substantially Equivalent | Varian Medical Systems, Inc. | accessdata.fda.gov |
| October 30, 2019 | K192504 | Treace Medical Concepts (TMC) Plating System | HRS | Substantially Equivalent | Treace Medical Concepts, Inc. | accessdata.fda.gov |
| June 13, 2019 | K183363 | Treace Medical Concepts (TMC) Snap-Off Screw System | HWC | Substantially Equivalent | Treace Medical Concepts, Inc. | accessdata.fda.gov |
| April 19, 2018 | K180102 | Embozene Color-Advanced Microspheres | NOY | Substantially Equivalent | Boston Scientific | accessdata.fda.gov |
| October 25, 2017 | K172617 | Treace Medical Concepts (TMC) Compression Screw System | HWC | Substantially Equivalent | Treace Medical Concepts, Inc. | accessdata.fda.gov |
| February 5, 2016 | K153489 | Cryocare CS Surgical System | GEH | Substantially Equivalent | Healthtronics | accessdata.fda.gov |
| September 9, 2015 | K151968 | Cryocare CS-3 Surgical System version 5 | GEH | Substantially Equivalent | Healthtronics | accessdata.fda.gov |
| June 25, 2015 | K141110 | CRYOCARE CS SURGICAL SYSTEM | GEH | Substantially Equivalent | Healthtronics | accessdata.fda.gov |
| August 7, 2014 | K141209 | EMBOZENE COLOR-ADVANCED MICROSPHERES, EMBOZENE OPAQUE (NON-COLORED) MICROSPHERES, ONCOZENE MICROSPHERES | KRD | Substantially Equivalent | Celonova Biosciences, Inc. | accessdata.fda.gov |
| January 25, 2002 | K011074 | CRYOCARE SURGICAL SYSTEM | GEH | Substantially Equivalent | Endocare, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| December 20, 2012 | 63933 | Class II | Terminated | HealthTronics Endocare 3.8mm RenalCryo Cryoprobe, R3.8L. The Endocare CryoProbe is an accessory probe intended for use with the CryoCare Surgical System, for freezing and ablation of tissue. | The Endocare 3.8mm RenalCryo Cryoprobe is being recalled because the label on the outer box has the incorrect expiration date. | accessdata.fda.gov |
| February 27, 2012 | 57924 | Not yet classified | Terminated | CRYO-206V and CRYO-206F Procedure Kit, which includes: Cryo Probes, Urethral Catheter, and temperature probes. Kit is intended to be used with the CryoCare Surgical System for freezing/ablating tissue by extreme cold tem | 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 at the connector. If the labeling error went undetected, the TempProbes would not be monitoring temperature in the area bel | accessdata.fda.gov |
| November 4, 2010 | 57214 | Not yet classified | Terminated | Incorrect Label: Endocare 2.4mm VARIABLE ATTACHED CRYOPROBE, REF: CVA 2400, LOT 2751. Correct Label: Endocare 2.4mm CRYOPROBE, REF: CRYO-44F (Sharp Tip). | Mislabeled : The label on the outer box and inner pouch of the EndoCare 2.4mm CryoProbe (CRYO-44F) inaccurately reference the CVA2400 (2.4mm Variable Probe aka: V-Probe). | accessdata.fda.gov |
| December 5, 2008 | 54004 | Not yet classified | Terminated | V-Probe, Endocare Cryo V Probe model # Cryo 206V. The product is used in a minimally invasive, percutaneous approach to treating prostate cancer in low, moderate and high risk patients. Prostate Cryoablation uses extreme | 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 Indications and Safety Review included with the Physician Training Materials and to reinforce additional safety informati | accessdata.fda.gov |
| October 25, 2002 | 25856 | Not yet classified | Terminated | SurgiFrost Cryosurgical Probes | Device design failure, connectivity. | accessdata.fda.gov |
Compare with other makers
- All makers of Unit, Cryosurgical, Accessories
- All makers of System, Ablation, Microwave And Accessories
- All makers of Agents, Embolic, For Treatment Of Uterine Fibroids
- All makers of Device, Vascular, For Promoting Embolization
- All makers of Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
- All makers of Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia
Updated January 17, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.