Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1037598

FEI Number

1037598

Entity Name

THERAGENICS CORP.

City/State/Country

BUFORD, GA, US

Establishment Address

5203 BRISTOL INDUSTRIAL WAY, BUFORD, GA 30518, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Theragenics Corporation (Owner Number: 1037598)

Owner / Operator Contact Address

5203 BRISTOL INDUSTRIAL WAY, --, Buford, GA 30518, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K043596

PMA Number

N/A

All Registered Proprietary Names

Fiducial Marker Needles Seed Implant Needle Set THERASEED(R) PALLADIUM-103 IMPLANT; MODEL 200 TheraStrand OSCERA 7 Manual IsoLoader 2 (MIL 2) Manual IsoLoader AnchorMarker Localization Needle (Anchorseed) TheraLoad/ Custom Loaded Needles

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KXK	Source, Brachytherapy, Radionuclide	Radiology	Class 2	892.5730	2007-11-05
IWJ	System, Applicator, Radionuclide, Manual	Radiology	Class 1	892.5650	2016-03-03
KXK	Source, Brachytherapy, Radionuclide	Radiology	Class 2	892.5730	2007-11-05
KXK	Source, Brachytherapy, Radionuclide	Radiology	Class 2	892.5730	2007-11-05
MTJ	Wax, Bone	Unknown	Class U	N/A	2007-11-06
IWJ	System, Applicator, Radionuclide, Manual	Radiology	Class 1	892.5650	1998-12-29
KXK	Source, Brachytherapy, Radionuclide	Radiology	Class 2	892.5730	2007-11-05
KXK	Source, Brachytherapy, Radionuclide	Radiology	Class 2	892.5730	2016-01-13
KXK	Source, Brachytherapy, Radionuclide	Radiology	Class 2	892.5730	2022-01-12
KXK	Source, Brachytherapy, Radionuclide	Radiology	Class 2	892.5730	2007-11-05

Official Correspondent

Kenneth Gaitor

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Theragenics Corporation

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3036802499	Theragenics Costa Rica Limitada	El Coyol, Alajuela, CR
3011623145	Theragenics Costa Rica Limitada	El Coyol Alajuela, CR
1649395	GALT MEDICAL CORP.	GARLAND, TX, US
3006283319	NeedleTech Products, Inc.	N Attleboro, MA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K973037	Avid N.I.T., Inc.	N.I.T., INC. RADIONUCLIDE SEED APPLICATOR, MODEL SA-1000	1998-01-27

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0040-2012	Worldwide Medical Technologies, LLC	1	Prostrate Seeding Applicator Needle. Product code PSS1820AT Packed in boxes of (25) with five Single Packs and four five packs or as singles or five packs. Worldwide Medical Technologies, LLC Used to introduce radionuclide seeds of 1-125 or Pd-103 into the body for radiation therapy. This device is typically used in the transperineal approach for placing radionuclide seeds in the prostate

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3014663932	GT MEDICAL TECHNOLOGIES, INC	Tempe, AZ, US
2020394	BARD PERIPHERAL VASCULAR, INC.	TEMPE, AZ, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1037598. Last updated year: 2026. Please use registration number 1037598 when referencing this establishment in official correspondence.