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I-125 RSLN [Radioactive Seed and Localization Needle]

by Isoaid, LLC

510(k) K141701

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 NumberK141701 Date5 Dec 2014ClearedStatusActive

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  • Withdrawn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, 27 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 I-125 RSLN is a pre-sterilized 18-gauge stainless steel needle containing a low activity I-125 Iodine Seed. It is designed to aid in the diagnosis of non-palpable tumors, lesions, or associated lymph nodes in the breast by defining tumor, lesion, or node location with a radioactive seed in preparation for excision.

The device is supplied as a single-use, pre-sterilized needle containing a laser welded Titanium capsule with Iodine-125 chemically affixed as silver iodide onto a silver rod. It is regulated under FDA 510K clearance with product code KXK and is intended for use in radiology procedures for localization of non-palpable breast abnormalities.

Other devices from Isoaid, LLC

Questions

AI-generated answers, 27 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 I-125 RSLN device used for?

    The I-125 RSLN is designed to aid in the diagnosis of non-palpable tumors, lesions, or associated lymph nodes in the breast by defining their location with a radioactive seed in preparation for surgical excision.

  • How is the I-125 RSLN supplied and is it single-use?

    The device is supplied as a single-use, pre-sterilized 18-gauge stainless steel needle containing a laser welded Titanium capsule with Iodine-125 chemically affixed as silver iodide onto a silver rod.

  • What is the regulatory status of the I-125 RSLN?

    The I-125 RSLN is regulated under FDA 510K clearance with product code KXK and is intended for use in radiology procedures for localization of non-palpable breast abnormalities.

  • What are the key specifications of the I-125 RSLN needle?

    The I-125 RSLN is an 18-gauge stainless steel needle that contains a low activity I-125 Iodine Seed. It is pre-sterilized and designed specifically for localization procedures in breast tissue.