GammaTile
GT Medical Technologies
GT Medical Technologies
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3005520039 | 3005520039 | GT Medical Technologies | 1 | N | 2026-01-01 | 350 Hills St Ste 106 RICHLAND WA US 99354 |
| 3014663932 | 3014663932 | GT MEDICAL TECHNOLOGIES, INC | 1 | N | 2026-01-01 | 1809 S Holbrook Ln STE 107 Tempe AZ US 85281 |
| 3017496466 | 3017496466 | GT Medical Technologies | 1 | N | 2026-01-01 | 350 Hills Street Suite 108 Richland WA US 99354 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 220496 | 1476457112 | K221539 | GammaTile | KXK | 2022-11-09 |
| 295254 | 1476457112 | K221539 | GammaTile | KXK | 2022-11-09 |
| 220496 | 1034768255 | K190839 | GammaTile | KXK | 2020-01-23 |
| 295254 | 1034768255 | K190839 | GammaTile | KXK | 2020-01-23 |
| 220496 | 1834542897 | K190296 | GammaTile | KXK | 2019-03-13 |
| 295254 | 1834542897 | K190296 | GammaTile | KXK | 2019-03-13 |
| 220496 | 1233654441 | K180515 | GammaTile | KXK | 2018-07-06 |
| 295254 | 1233654441 | K180515 | GammaTile | KXK | 2018-07-06 |
| 328005 | 2060323978 | K092458 | PROXCELAN CS-131PRELOADED STRANDS, MODEL PL-1, PROXCELAN CS-131 PRELOADED STRANDS IN 18 GUAGE NEEDLES, MODEL PL-2 | KXK | 2009-08-28 |
| 328005 | 1786204308 | K092136 | PROXCELAN CS-131 PRELOADED BRAIDED STRANDS, MODEL: PL-5 | KXK | 2009-08-07 |
| 328005 | 1230971982 | K062384 | CESIUM-131 STRAND, STRAND PRELOAD, PRELOAD, S-CARTRIDGE | KXK | 2006-11-09 |
| 328005 | 2065807182 | K030162 | LAWRENCE CSERION, MODEL CS-1 | KXK | 2003-03-28 |
| 220496 | 1720195335 | ||||
| 295254 | 1720195335 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| KXK | 12 | 2022-11-09 |
PMN#
GUDID#
PL-8 - Cesium-131 Implant Devices combined with MRI Markers will be used to facilitate the anatomical location of seeds after they have been implanted in the prostate of a patient with confirmed prostatic malignancy. The PL-8 device is preloaded strands with Markers in 18G needles.
2024-04-29
PL-7
2024-04-29
PL-5M
2024-04-29
PL-4NS
2024-04-29
PL-4
2024-04-29
PL-3
2024-04-29
PL-2
2024-04-29
PL-5
2024-04-29
PL-1
2024-04-29
CS-1 - CS-1NS
2024-04-29
CS-1
2024-04-29
GammaTile - Preloaded flexible braided strands with Cs-131 Brachytherapy seeds inside a purified collagen carrier
2024-04-29
GammaTile - Preloaded flexible braided strands with Cs-131 Brachytherapy seeds inside a purified collagen carrier
2024-04-29
GammaTile Radiation Shielding Tray - GT-002
2022-09-13
GammaTile™ - Preloaded flexible braided strands with Cs-131 Brachytherapy seeds inside a purified collagen carrier
2018-09-01
GammaTile™ - Preloaded flexible braided strands with Cs-131 Brachytherapy seeds inside a purified collagen carrier
2018-09-01