FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Universal Cylinder Applicator Family, Universal Segmented Cylinder Applicator Set, Universal Stump Applicator Set, Universal Cervix Probe Sets, odd lengths and even lengths, Universal Titanium Cervix Probe Sets, odd lengths and even lengths
K Number: K172611
·
Decision Mar 21, 2018
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
206
Applicant Total
170
Review Days
202
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Basic Information
- Device Name
- Universal Cylinder Applicator Family, Universal Segmented Cylinder Applicator Set, Universal Stump Applicator Set, Universal Cervix Probe Sets, odd lengths and even lengths, Universal Titanium Cervix Probe Sets, odd lengths and even lengths
- K Number
- K172611
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.5700
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Varian Medical Systems, Inc.
- Date Received
- August 31, 2017
- Decision Date
- March 21, 2018
- Product Code
- JAQ
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JAQ | System, Applicator, Radionuclide, Remote-Controlled | FDA class 2 | Radiology |
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