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Freiburg Flap Applicator Set, Part Number 089.095

by Nucletron Corp.

510(k) K983338

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK983338 Date20 Apr 1999ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 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  • Withdrawn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
JAQ
Device Class
Class II
Regulation
21 CFR Part 892.5700
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 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 Freiburg Flap Applicator Set is a remote-controlled radionuclide applicator designed for skin surface and intraoperative brachytherapy procedures. It is part of a closed system intended to deliver precise radiation doses to targeted treatment areas during radiology-based therapies.

This applicator set is supplied as a reusable device and is intended for use with Nucletron’s remote afterloading equipment, including the mHDR, mHDR-Classic, and mPDR systems. It has received FDA 510(k) clearance under the product code JAQ, classified as a Class II device under regulation number 892.5700. The device is regulated for radiology applications and is not intended for MRI use.

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