Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008262715

FEI Number

3008262715

Entity Name

Varian Medical Systems, Inc

City/State/Country

Austin, TX, US

Establishment Address

9825 Spectrum Drive, Building 2, Austin, TX 78717, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Varian Medical Systems, Inc (Owner Number: 2914292)

Owner / Operator Contact Address

3100 Hansen Way, --, Palo Alto, CA 94304, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K172617

PMA Number

N/A

All Registered Proprietary Names

OmniBone Bone Marrow Biopsy Kit with Power Driver, OmniBone Bone Biopsy Kit with Power Driver MicroThermX Microwave Ablation System - Tabletop Stand (MTX-180-T2) MicroThermX Microwave Ablation System - Mobile Cart (MTX-180) Cryocare CS Surgical System TMC Snap-Off Screw System Urethral Warming Catheter Kit Cryocare CS Basic System (CRYO-CS-3 BASIC) Tempprobe Short (CRYO-55F) Cryoprobe PERC 2.4MM Slimline Long (PCS-24L) Endocare 1.7 mm RenalCryo Cryoprobe (RS-17) Cryoprobe Renal 2.4MM Slimline (RS-24) Endocare 1.7 mm PerCryo Round Ice Cryoprobe (PCS-17R) Endocare Prostate Procedure Probe Pack 6 x CVA2400 6 x CRYO-55-F 1 x CRYO-77 (CRYO-207V) Endocare 1.7 mm RenalCryo Long Shaft Cryoprobe (RS-17L) Endocare TempProbe Device (CRYO-54F) Endocare 1.7mm PerCryo Short Cryoprobe (PCS-17RS) Endocare Cryocare CS System Version 5 (CRYO-CS-3 Version 5) Endocare Right-Angle 2.4mm V-Probe Cryoprobe (CVA2400RA) Cryoprobe Renal 1.7MM Slimline Long (RS-17L) Endocare 1.7mm PerCryo Cryoprobe (PCS-17) Cryoprobe PERC 2.4MM Slimline (PCS-24) Endocare 1.7mm PerCryo Cryoprobe Oblong Ice (PCS-17) Endocare Prostate Procedure Probe Pack 6 (CRYO-207V) Endocare 3.8mm Long Shaft RenalCryo Cryoprobe (R3.8L) Endocare 2.4 mm RenalCryo Cryoprobe (RS-24) Endocare 2.4mm Long Shaft RenalCryo (RS-24L) Endocare Prostate Procedure Probe Pack 4 (CRYO-204V) Endocare 1.7mm Round Ice PerCryo Cryoprobe (PCS-17R) Endocare 2.4 mm PerCryo Long Shaft Cryoprobe (PCS-24L) Endocare 2.4mm RenalCryo Long Shaft (RS-24L) Endocare 3.8mm RenalCryo Cryoprobe (R3.8) Endocare 1.7mm Short PerCryo (PCS-17RS) Endocare Cryocare CS System Basic (CRYO-CS-3 BASIC) Round ice short length (PCS-17RS) Endocare Prostate Procedure Probe Pack 4 x CVA2400 6 x CRYO-55-F 1 x CRYO-77 (CRYO-204V) Cryoprobe Renal 1.7MM Slimline (RS-17) Endocare 2.4 mm PerCryo Cryoprobe (PCS-24) Cryoprobe Renal 2.4MM Slimline Long (RS-24L) Endocare TempProbe Device (CRYO-55F) Endocare 2.4mm V-Probe Cryoprobe (CVA2400) Endocare 2.4mm PerCryo Cryoprobe Oblong Ice (PCS-24) ONCOZENE Microspheres Cryocare CS Surgical System TANDEM Microspheres ONCOZENE® Microspheres Temperature Sensor Probe (ABL-18TP20) Embozene Color-Advanced Microspheres TMC Compression Screw System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2024-09-04
NEY	System, Ablation, Microwave And Accessories	General, Plastic Surgery	Class 2	878.4400	2020-01-06
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2024-09-23
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2020-01-07
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2022-01-18
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2020-01-06
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2024-10-24
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2024-09-23
NAJ	Agents, Embolic, For Treatment Of Uterine Fibroids	Cardiovascular	Class 2	870.3300	2022-11-02
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2022-11-02
NEY	System, Ablation, Microwave And Accessories	General, Plastic Surgery	Class 2	878.4400	2024-07-25
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2022-11-02
NAJ	Agents, Embolic, For Treatment Of Uterine Fibroids	Cardiovascular	Class 2	870.3300	2022-11-02
NOY	Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia	Gastroenterology, Urology	Class 2	876.5550	2022-11-02
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2020-01-07

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Varian Medical Systems, Inc

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3007157255	Varian Medical Systems, Inc.	Atlanta, GA, US
3007791541	Varian Medical Systems China Co., Ltd.	Beijing, CN
3010658895	Varian Medical Systems Particle Therapy GmbH & Co. KG	Troisdorf North Rhine-Westphalia, DE
3009754495	Varian Medical Systems International India Private Ltd	Pune Maharashtra, IN
3025765259	Varian Medical Systems Haan GmbH Manufacturing site Kemnath	Kemnath Bavaria, DE

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K172344	Medax Srl Unipersonale	Medax Biopsy Systems II (MEDONE, MEDCUT, MEDEM, MEDBONE, MEDLOCK)	2017-11-13
K190651	Erbe Elektromedizin GmbH	ERBECRYO 2 Cryosurgical Unit; ERBECRYO 2 1-pedal footswitch, Extension cable f. ERBECRYO 2 footswitch; Flexible Cryoprobe; ERBECRYO 2 Cart, VIO-Cart, Wire basket; Connecting hoses, switching valves, adapter	2020-01-07
K760953	Spembly Medical , Ltd.	DEEP FREEZE SYSTEM (DFS-30)	1976-11-16
K062348	Medtronic Neurosurgery	TIMESH SELF DRILLING SCREW	2006-09-08
K063244	Arc Surgical, LLC	ARC SURGICAL BONE REDUCTION SCREW	2006-12-27

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2024	Bard Peripheral Vascular Inc	2	Bard Marquee Disposable Core Biopsy Instrument Kit, REF: MQK2016
Z-0028-2013	Remington Medical Inc.	2	Automatic Cutting Needles, Soft Tissue Biopsy Needle, NAC-1820M, Sterile, Remington Medical, Inc., 5830 Meadowridge Court, Alpharetta, GA 30005. Prostate Biopsy Needles shall be single use only and are to be used by a Urologist in a healthcare setting to obtain needle biopsies of the prostate. The needles are compatible with the Bard Magnum biopsy instrument. The needles have an echogenic tip for accurate placement under ultrasound guidance and centimeter markings along the cannula to facilitate depth placement.
Z-0042-2014	Atossa Genetics, Inc.	2	Brand: The ForeCYTE Breast Health Test, Mammary Aspiration Specimen Cytology Test (MASCT), MASCT System Kits, Clarity System Kits, MASCT Patient Sample Kits & Clarity Patient Sample Kits Instrument, Biopsy. The MASCT System Kit, Patient Sample Kits, or the Nipple Aspirate Fluid Laboratory Kit has the following codes: PRODUCT CODE: AG-MASCT; AG-FC5; DTG-MASCT, DTG-FC5, and NRLBH-5. PART NUMBER: 9002513; 9002513MD; 9002528; 9002528MD; 9002587; 9002614; and 9002717MD. THE MASCT SYSTEM KIT CONSISTS OF: 1. MASCT Breast Pump; 2. Instructions for Use (IFU); 3. Heating Pad; 4. Timer; 5. Saccomono's Fixative; 6. Nu Prep Gel; 7. Welcome and Training Materials Coversheet; 8. MASCT System Order Form; 9. ForeCYTE Training Video DVD; 10. MASCT System Instructions with pictures - pink; THE PATIENT SAMPLE KIT CONSISTS OF: 1. Two (2) flower assemblies (e.g., filter, filter retainer, and filter holder); 2. Instructions for Use (IFU); 3. Two (2) specimen collection devices; 4. Two (2) breast bags for transporting the specimen collection container; 5. Barcode labels; 6. Saccomono's Fixative; 7. Nu Prep Gel; 8. MASCT System package insert; 9. ForeCYTE Test Requisition Form; 10. Patient Information Sheet; 11. Atossa Patient Information; 12. FED EX Clinical PAK; 13. MASCT System Order Form; 14. FED EX Pouch; 15. FED EX Airbill; Product Usage: The MASCT Device is intended for use in the collection of nipple aspirate fluid for cytological testing. The collected fluid can be used in the determination and/or differentiation of normal versus premalignant versus malignant cells.
Z-0044-2018	Bard Peripheral Vascular Inc	2	BARD MAX-CORE Disposable Core Biopsy Instrument, Product Codes - MC1410, 14 g x 10 cm; MC1616, 16 g x 16 cm; MC1816, 18 g x 16 cm; MC1820, 18 g x 20 cm; MC1825, 18 g x 25 cm. The core needle biopsy device is intended for use in obtaining biopsies from soft tissues.
Z-0210-2022	Covidien Llc	2	Covidien Emprint Ablation Catheter with Thermosphere Technology Bronchoscopic Ablation, CFN CA108L1

Similar Registrations

Registration Number	Establishment Name	Location
3042940295	NEONAVIA AB	Vallentuna Stockholm, SE
3038611181	XAGA SURGICAL AB	Eslov Skane, SE
1018233	C.R. BARD, INC.	COVINGTON, GA, US
2648623	STERIS ISOMEDIX PUERTO RICO, INC.	Alts De Cerro Gordo 3&4, PR, US
3010515547	PROMISEMED HANGZHOU MEDITECH CO.,LTD.	Hangzhou Zhejiang, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008262715. Last updated year: 2026. Please use registration number 3008262715 when referencing this establishment in official correspondence.