Theragenics Corp.
Buford, GA, US
THERAGENICS CORP. appears in FDA device records in Buford, GA. FDA records list 5 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 5 510(k) clearances for Theragenics Corp. between 1987 and 2011. The busiest year on record is 1987, with 1. The most recent is 2011, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1987 | 1 |
| 2001 | 1 |
| 2005 | 1 |
| 2007 | 1 |
| 2011 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K103319 | I-SEED | KXK | Substantially Equivalent | |
| K072296 | POIINT OF CARE STRANDING SYSTEM, MODE 1004-00 | KXK | Substantially Equivalent | |
| K043596 | THERALOAD CUSTOM LOADED NEEDLES, MODELS 200 AND 125.S06 | KXK | Substantially Equivalent | |
| K010283 | THERASEED(R) PALLADIUM-103 IMPLANT; MODEL 200 | KXK | Substantially Equivalent | |
| K874787 | MODIFIED PALLADIUM SEED MODEL 100 | IWI | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1037598 | 1037598 | THERAGENICS CORP. | 5203 BRISTOL INDUSTRIAL WAY, BUFORD, GA 30518 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0643-2019 | 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 | Class II | Terminated | |
| Z-1020-2009 | 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 intended for consumption during the brachytherapy procedure. Unused (unopened) product is not intended to be inventoried. by the attending physician. | Some pouches were found to have weak seals potentially compromising sterility. | Terminated | ||
| Z-0974-05 | 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. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain