Skip to content

SMD-Sr90-DA Radionuclide Brachytherapy Source

by Salutaris Medical Devices, Inc.

510(k) K163206

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK163206 Date15 Dec 2016ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

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

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The SMD-Sr90-DA Radionuclide Brachytherapy Source is a Class II medical device designed to function as a radiation source within a manual brachytherapy applicator system. It contains Strontium-90 and is intended for use in episcleral brachytherapy procedures.

The device is supplied as a single-use, sterile unit and is regulated under FDA product code KXK with regulation number 892.5730. It is cleared for use in the United States under the 510(k) premarket notification pathway, with the most recent clearance granted on December 15, 2016, under K163206. Storage conditions and specific handling instructions are not detailed in the available data.

Other devices from Salutaris Medical Devices, Inc.

Questions

AI-generated answers, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the SMD-Sr90-DA used for?

    It is a radionuclide brachytherapy source containing Strontium-90, designed to be placed within a manual brachytherapy applicator system. Its intended use is specifically for episcleral brachytherapy procedures.

  • How is the device supplied?

    The device is supplied as a single-use, sterile unit. This packaging ensures it is ready for immediate clinical use without requiring additional sterilization by the end user.

  • Is the SMD-Sr90-DA reusable?

    No, it is designed strictly as a single-use device. After a single procedure, it must be disposed of according to institutional protocols for radioactive waste.

  • What regulatory pathway was used for clearance?

    The device was cleared through the FDA's 510(k) premarket notification pathway. It is classified as a Class II device under product code KXK and regulation number 892.5730.

  • Are specific storage conditions provided?

    The available device data does not detail specific storage conditions or handling instructions. Users should consult the manufacturer's labeling or contact Salutaris Medical Devices, Inc. for specific storage requirements.