Skip to content

125-IMPLANT Seeds, Model STM1250

by Sourcetech Medical, LLC

510(k) K991881

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 NumberK991881 Date16 Mar 2000ClearedStatusActive

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  • Withdrawn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, 25 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 125-Implant Seeds, Model STM1250 are brachytherapy radionuclide devices used for implantation. They are classified as Class II medical devices under 21 CFR 892.5730.

These seeds are supplied as single-use devices and are intended for use in brachytherapy procedures. They are manufactured by Sourcetech Medical, LLC and are subject to FDA 510(k) clearance (K991881).

Other devices from Sourcetech Medical, LLC

Questions

AI-generated answers, 25 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 125-Implant Seeds, Model STM1250 used for?

    The 125-Implant Seeds, Model STM1250 are brachytherapy radionuclide devices intended for implantation during brachytherapy procedures.

  • How are the 125-Implant Seeds, Model STM1250 supplied?

    The 125-Implant Seeds, Model STM1250 are supplied as single-use devices.

  • What is the regulatory status of the 125-Implant Seeds, Model STM1250?

    The 125-Implant Seeds, Model STM1250 are subject to FDA 510(k) clearance (K991881).