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GammaTile

by GT Medical Technologies 3 variants

510(k) K190296

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 5 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 5 Oct 2026.

Regulatory status

as of registry sync 5 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK190296 Date13 Mar 2019ClearedStatusActive

Official records

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  • Withdrawn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

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 1 Oct 2026

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

The GammaTile is a Source, Brachytherapy, Radionuclide device, classified as a Class II medical device under FDA regulation 892.5730. It is a bioabsorbable collagen implant embedded with radioactive seeds, designed to deliver localized radiation therapy directly to the surgical cavity following tumor resection in brain tumor patients. This device is intended for use in radiology settings to provide targeted treatment to the tumor bed, reducing the risk of recurrence by delivering precise radiation internally.

GammaTile is supplied as a single-use, sterile implant intended for surgical placement by a healthcare provider during the removal of operable brain tumors. The device is regulated under FDA 510(k) clearance (K190296) and is classified under the Radiology specialty. It is not MRI-safe, and its use requires adherence to standard radiation safety protocols. Storage and handling follow sterile surgical implant guidelines, with no reusable components. The device is distributed by GT Medical Technologies, Tempe, AZ.

Similar devices

Other devices filed under FDA product code KXK (Source, Brachytherapy, Radionuclide).

Other devices from GT Medical Technologies

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