Data / Medical devices / United States / Theragenics Corp.
Theragenics Corp.: FDA-registered device maker in Buford, GA, United States, 11 510(k) clearances
Theragenics Corp. is registered with the FDA (registration 1037598) in Buford, GA, United States. It lists 3 device types. The FDA files 11 510(k) clearances under its listings, the newest dated October 18, 2011. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1037598
- Address
- 5203 Bristol Industrial Way, Buford, GA, United States, 30518
- Owner or operator
- Theragenics Corporation (1037598)
- Roles
- Manufacturer, Specification developer
- First device listed
- December 29, 1998
- Registered through
- 2026
- Brand names listed
- 910 Seeding Spacers, AnchorMarker, Fiducial Marker Needles, I-SEED (AgX100), Localization Needle (Anchorseed), Manual IsoLoader, Manual IsoLoader 2 (MIL 2), OSCERA 7 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Source, Brachytherapy, Radionuclide | KXK | 2 | Manufacturer | accessdata.fda.gov |
| System, Applicator, Radionuclide, Manual | IWJ | 1 | Manufacturer | accessdata.fda.gov |
| Wax, Bone | MTJ | U | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 18, 2011 | K111979 | RADIOACTIVE SEED LOCALIZATION NEEDLE | KXK | Substantially Equivalent | Biocompatibles, Inc. | accessdata.fda.gov |
| January 3, 2011 | K103319 | I-SEED | KXK | Substantially Equivalent | Theragenics Corp. | accessdata.fda.gov |
| January 8, 2009 | K083274 | WORLDWIDE MEDICAL TECHNOLOGIES ANCHOR MARKER, MARKER STRAND AND MARKER | KXK | Substantially Equivalent | Biocompatibles, Inc. | accessdata.fda.gov |
| September 26, 2007 | K072296 | POIINT OF CARE STRANDING SYSTEM, MODE 1004-00 | KXK | Substantially Equivalent | Theragenics Corp. | accessdata.fda.gov |
| July 18, 2007 | K071550 | PRE-WAXED NEEDLES WITH GOLD FIDUCIARY MARKERS | KXK | Substantially Equivalent | Cp Medical | accessdata.fda.gov |
| November 2, 2006 | K060987 | OSCERA7 SYNTHETIC ABSORBABLE BONE WAX, MODEL OS31 | MTJ | Substantially Equivalent | Cp Medical | accessdata.fda.gov |
| January 26, 2005 | K043596 | THERALOAD CUSTOM LOADED NEEDLES, MODELS 200 AND 125.S06 | KXK | Substantially Equivalent | Theragenics Corp. | accessdata.fda.gov |
| April 8, 2004 | K040339 | BRACHYTHERAPY STRAND DEVICE | KXK | Substantially Equivalent | Bebig Isotopen-Und Medizintechnik GmbH | accessdata.fda.gov |
| September 4, 2001 | K010621 | ACCU-SPACE ABSORBABLE SEEDING SPACERS | KXK | Substantially Equivalent | Cp Medical | accessdata.fda.gov |
| April 26, 2001 | K010283 | THERASEED(R) PALLADIUM-103 IMPLANT; MODEL 200 | KXK | Substantially Equivalent | Theragenics Corp. | accessdata.fda.gov |
| January 23, 1998 | K974118 | WORLDWIDE MEDICAL TECHNOLOGIES SEED IMPLANT NEEDLE SET | IWJ | Substantially Equivalent | Worldwide Medical Technologies, LLC | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| October 9, 2018 | 81537 | Class II | Terminated | Theragenics Applicator Needle (18g x 20cm) The device is comprised four basic elements; a wire stylus with plastic handle, a plastic needle hub, a protective needle sleeve and the hollow steel needle. | Some of the pouches containing Brachytherapy Applicator Needles (18g x 20cm) were not sealed | accessdata.fda.gov |
| December 8, 2008 | 51177 | Not yet classified | Terminated | Spacers of varying lengths used with the InSTANT Stranding System, Part numbers: TG3138, TG3139, TG3140, TG3141 and TG3142. Theragenics Corporation, 5203 Bristol Industrial Way, Buford GA 30518. The spacer product is int | Some pouches were found to have weak seals potentially compromising sterility. | accessdata.fda.gov |
| May 16, 2005 | 32194 | Not yet classified | Terminated | PG910 Spacers, Part number SP101, loaded into Bard Express Seeding Cartridges containing TheraSeed Pd-103 devices. The product is shipped non-sterile in a foil pouch, packed 50 loose spacers per pouch. | The spacers loaded in the seeding cartridges were expired and/or the extra loose spacers were labeled with an incorrect expiration date. | accessdata.fda.gov |
Compare with other makers
- All makers of Source, Brachytherapy, Radionuclide
- All makers of System, Applicator, Radionuclide, Manual
- All makers of Wax, Bone
Updated October 18, 2011. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.