FDA Registration
Active
🇺🇸 United States
Endocare TempProbe Device (CRYO-54F)
Reg #: 3008262715
·
FEI: 3008262715
·
Expires 2025
Products
1
Proprietary Names
35
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Varian Medical Systems, Inc
- Registration Number
- 3008262715
- FEI Number
- 3008262715
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 9825 Spectrum Drive, Building 2
- City
- Austin
- State
- TX
- ZIP
- 78717
- Country
- US
Regulatory Submissions
- 510(k) Number
- K153489
Owner / Operator
- Firm Name
- Varian Medical Systems, Inc
- Operator Number
- 2914292
- Address
- 3100 Hansen Way, --
- City
- Palo Alto
- State
- CA
- Postal Code
- 94304
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Unit, Cryosurgical, Accessories | GEH | Class 2 | General, Plastic Surgery | No | 2020-01-06 |
Proprietary Names
Endocare TempProbe Device (CRYO-54F)
Endocare 2.4mm Long Shaft RenalCryo (RS-24L)
Endocare 2.4 mm PerCryo Cryoprobe (PCS-24)
Endocare 3.8mm Long Shaft RenalCryo Cryoprobe (R3.8L)
Cryoprobe Renal 1.7MM Slimline Long (RS-17L)
Endocare Prostate Procedure Probe Pack 6 x CVA2400 6 x CRYO-55-F 1 x CRYO-77 (CRYO-207V)
Endocare 1.7mm Round Ice PerCryo Cryoprobe (PCS-17R)
Endocare TempProbe Device (CRYO-55F)
Endocare 2.4mm V-Probe Cryoprobe (CVA2400)
Endocare 2.4mm PerCryo Cryoprobe Oblong Ice (PCS-24)
Endocare 1.7mm PerCryo Short Cryoprobe (PCS-17RS)
Endocare Prostate Procedure Probe Pack 4 x CVA2400 6 x CRYO-55-F 1 x CRYO-77 (CRYO-204V)
Endocare 1.7mm Short PerCryo (PCS-17RS)
Cryoprobe Renal 2.4MM Slimline (RS-24)
Endocare 2.4mm RenalCryo Long Shaft (RS-24L)
Cryoprobe Renal 1.7MM Slimline (RS-17)
Endocare 1.7mm PerCryo Cryoprobe Oblong Ice (PCS-17)
Endocare Prostate Procedure Probe Pack 4 (CRYO-204V)
Cryoprobe PERC 2.4MM Slimline Long (PCS-24L)
Round ice short length (PCS-17RS)
Endocare 1.7 mm RenalCryo Cryoprobe (RS-17)
Endocare Cryocare CS System Version 5 (CRYO-CS-3 Version 5)
Tempprobe Short (CRYO-55F)
Endocare Right-Angle 2.4mm V-Probe Cryoprobe (CVA2400RA)
Endocare 3.8mm RenalCryo Cryoprobe (R3.8)
Cryoprobe Renal 2.4MM Slimline Long (RS-24L)
Endocare 2.4 mm PerCryo Long Shaft Cryoprobe (PCS-24L)
Cryocare CS Basic System (CRYO-CS-3 BASIC)
Endocare 1.7 mm RenalCryo Long Shaft Cryoprobe (RS-17L)
Cryoprobe PERC 2.4MM Slimline (PCS-24)
Endocare 2.4 mm RenalCryo Cryoprobe (RS-24)
Endocare 1.7mm PerCryo Cryoprobe (PCS-17)
Endocare 1.7 mm PerCryo Round Ice Cryoprobe (PCS-17R)
Endocare Prostate Procedure Probe Pack 6 (CRYO-207V)
Endocare Cryocare CS System Basic (CRYO-CS-3 BASIC)
Establishment Types
Manufacture Medical Device