GammaTile

Source, Brachytherapy, Radionuclide

GT Medical Technologies

The following data is part of a premarket notification filed by Gt Medical Technologies with the FDA for Gammatile.

Pre-market Notification Details

Device IDK221539
510k NumberK221539
Device Name:GammaTile
ClassificationSource, Brachytherapy, Radionuclide
Applicant GT Medical Technologies 1809 S Holbrook Lane Suite 107 Tempe,  AZ  85281
ContactJessica Newhard
CorrespondentJessica Newhard
GT Medical Technologies 1809 S Holbrook Lane Suite 107 Tempe,  AZ  85281
Product CodeKXK  
CFR Regulation Number892.5730 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-05-27
Decision Date2022-11-09

Trademark Results [GammaTile]

Mark Image

Registration | Serial
Company
Trademark
Application Date
GAMMATILE
GAMMATILE
88226299 not registered Live/Pending
GT MEDICAL TECHNOLOGIES, INC.
2018-12-12
GAMMATILE
GAMMATILE
86570994 not registered Dead/Abandoned
GT MEDICAL TECHNOLOGIES, INC.
2015-03-20

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