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Iridium 192 Wires

by Syncor Intl. Corp. 510(k)

Active United States

510(k) K850163

Overview

The Iridium 192 Wires are a radioactive source wire designed for use in brachytherapy procedures within the radiology specialty. These wires incorporate iridium-192, a gamma-emitting isotope, to deliver precise radiation doses for targeted tumor treatment or other interventional radiology applications.

Supplied as a single-use device under FDA 510(k) clearance (K850163), the Iridium 192 Wires are classified as Class II and regulated under FDA regulation number 892.5730. They are intended for sterile use in controlled clinical settings and must be handled and disposed of according to radioactive material safety protocols. The device is available in a standardized form as referenced by product code IWA.

AI-generated from registry data, 19 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK850163 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 6 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
IWA
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 primary use of the Iridium 192 Wires in medical procedures?

    The Iridium 192 Wires are designed specifically for brachytherapy procedures within radiology. They deliver targeted radiation doses using iridium-192, a gamma-emitting isotope, to treat tumors or other interventional radiology applications by precisely controlling the radiation exposure in a controlled clinical setting.

  • Are the Iridium 192 Wires intended for single-use or can they be reused?

    The Iridium 192 Wires are explicitly supplied as a single-use device. This is due to their radioactive nature and the need for strict safety protocols, which necessitate that each wire is used once and then disposed of properly to avoid contamination or exposure risks.

  • What safety measures must be followed when handling the Iridium 192 Wires?

    Since these wires contain a radioactive source (iridium-192), they must be handled according to radioactive material safety protocols. This includes proper shielding, disposal procedures, and adherence to clinical guidelines to minimize exposure risk to both patients and staff during and after use.

  • How are the Iridium 192 Wires classified and regulated by the FDA?

    The Iridium 192 Wires are classified as a Class II medical device under FDA regulation number 892.5730. They were cleared through a traditional 510(k) process (K850163) and are regulated under the Radiology specialty, with a decision of Substantially Equivalent (SESE) by the Radiology (RA) Advisory Committee.

  • Are the Iridium 192 Wires sterile, and how should they be stored?

    Yes, the Iridium 192 Wires are intended for sterile use in controlled clinical settings. While storage specifics aren’t detailed in the data, radioactive devices like these typically require secure, shielded storage to prevent unauthorized access and ensure safety. Always follow manufacturer guidelines and local regulations for proper handling and storage.