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CS137 Sealed Sources

by Syncor Intl. Corp. 510(k)

Active United States

510(k) K850434

Overview

The CS137 Sealed Sources are brachytherapy devices designed for radionuclide-based radiation therapy. These sealed sources incorporate radioactive material encapsulated in a protective housing to deliver precise internal radiation doses for medical treatments, primarily in radiology applications.

These sources are intended for single-use and are regulated under FDA 510(k) clearance (K850434) as Class II devices under product code KXK. They fall under regulation 892.5730 and are authorized for use in radiology settings, adhering to traditional 510(k) review standards. No additional sterility or reusable specifications are noted in the regulatory data.

AI-generated from registry data, 1 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK850434 Date26 Mar 1985ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 5 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
KXK
Device Class
Class II
Regulation
21 CFR Part 892.5730
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the CS137 Sealed Sources device used for?

    The CS137 Sealed Sources are brachytherapy devices designed specifically for radionuclide-based radiation therapy. They are intended to deliver controlled internal radiation doses in radiology settings, ensuring targeted treatment for medical conditions requiring localized radiation exposure.

  • Are the CS137 Sealed Sources meant for single-use or reuse?

    The CS137 Sealed Sources are explicitly designed for single-use only. This design ensures patient safety and sterility, as reuse could compromise the integrity of the radioactive encapsulation and introduce contamination risks.

  • What regulatory pathway does the CS137 Sealed Sources follow?

    The CS137 Sealed Sources are classified as Class II devices under product code KXK and are authorized for use in radiology through FDA 510(k) clearance (K850434). They adhere to traditional 510(k) review standards and are regulated under 21 CFR 892.5730, ensuring compliance with established safety and performance criteria.

  • What types of medical specialties use the CS137 Sealed Sources?

    The CS137 Sealed Sources are primarily utilized in radiology applications. They are intended for clinicians and facilities specializing in radiation therapy, where precise internal radiation delivery is required for treating specific medical conditions.

  • Are there any specific storage requirements for the CS137 Sealed Sources?

    While the provided data does not specify detailed storage instructions, sealed radioactive sources like the CS137 must generally be stored in a secure, shielded environment to prevent unauthorized access and to minimize radiation exposure to personnel. Proper handling and storage protocols, as outlined in radiation safety guidelines, should always be followed.