Shielded Applicator Set, Cervical Stop
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K151657 FDA 510(k)
- FDA Product Code
- JAQ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.5700 FDA 510(k)
- Regulation Number
- 892.5700 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Shielded Applicator Set, Cervical Stop is a System, Applicator, Radionuclide, Remote-Controlled, designed for targeted radiation therapy. It is intended for use in radiology procedures to deliver precise radiation doses to cervical regions, incorporating shielding to protect surrounding tissues and personnel.
This device is supplied as a reusable set, with components intended for use in controlled clinical environments such as radiation oncology departments. It is classified as a Class II medical device under FDA regulations (892.5700) and has received FDA 510K clearance and MDD authorization. The set includes multiple applicator variants, each identified by unique reference codes, and must be handled in accordance with radiation safety protocols.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K151657 | Class II | Active |
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Manufacturer
- Manufacturer
- Varian Medical Systems, Inc.
Sources (2)
- FDA 510(k) K151657 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 18, 2026