System, Applicator, Radionuclide, Remote Controlled
Kobold, LLC
KOBOLD
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3009829958 | 3009829958 | KOBOLD | 1 | N | 2020-04-25 | 23403 E Mission Ave Suite 220E Liberty Lake WA US 99019 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 145368 | 1518055965 | K170203 | System, Applicator, Radionuclide, Remote Controlled | JAQ | 2017-06-01 |
| 145368 | 1329721358 | K160610 | Kobold Fletcher-model Tandem and Ovoid Applicator Set, Kobold Henschke-model Tandem and Ovoid Applicator Set, Kobold Vaginal Cylinder Applicator Set, Kobold Miami Cylinder Applicator Set | JAQ | 2017-02-13 |
| 145368 | 1170830253 | K142330 | Kobold Ring and Tandem Applicator Set | JAQ | 2015-04-09 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| JAQ | 3 | 2017-06-01 |
PMN#
GUDID#
Kobold® Prostate HDR Stepper Template - 17 ga/4 Fr - Labelled with CE
2019-11-20
Kobold® Prostate HDR Stepper Template - 16 ga/5 Fr - Labelled with CE
2019-11-20
Kobold® Prostate HDR Template - 18 ga - Labelled with CE
2019-11-20
Kobold® Prostate HDR Template - 17 ga/4 Fr - Labelled with CE
2019-11-20
Kobold® Prostate HDR Template - 16 ga/5 Fr - Labelled with CE
2019-11-20
Kobold® Prostate HDR Stepper Template - 6 Fr - Labelled with CE
2019-12-09
Kobold® Prostate HDR Template - 16 ga/5 Fr - 802-000
2017-07-18
Kobold® Prostate HDR Template - 17 ga/4 Fr - 803-000
2017-07-18
Kobold® Prostate HDR Template - 18 ga - 804-000
2017-07-18
Kobold® Prostate HDR Stepper Template - 16 ga/5 Fr - 811-000
2017-07-18
Kobold® Prostate HDR Stepper Template - 17 ga/4 Fr - 812-000
2017-07-19
Kobold® Henschke-model Tandem and Ovoid Applicator Set (E) - Labelled with CE mark
2019-03-25
Kobold® Fletcher-model Tandem and Barrel Ovoid Applicator Set (E) - Labelled with CE mark
2019-03-25
Kobold® Fletcher-model Tandem and Cylinder Ovoid Applicator Set (E) - Labelled with CE mark
2019-03-25
Kobold® Vaginal Cylinder Applicator Set (E) - Labelled with CE mark
2019-03-25
Kobold® Henschke-model Tandem and Ovoid Applicator Set (E) - 704-000
2016-09-23
Kobold® Fletcher-model Tandem and Barrel Ovoid Applicator Set (E) - 708-001
2016-09-23
Kobold® Fletcher-model Tandem and Cylinder Ovoid Applicator Set (E) - 708-002
2016-09-23
Kobold® Vaginal Cylinder Applicator Set (E) - 715-000
2016-09-23
Kobold® Prone Breast Board - 325-000
2016-09-23
Kobold® Prone Belly Board - 315-000
2016-09-23
Kobold® Interstitial Extender Set - 714-001
2016-09-23
Kobold® Fletcher-model Tandem and Ovoid Applicator Set (V) - 701-000
2016-09-23
Kobold® Henschke-model Tandem and Ovoid Applicator Set (V) - 702-000
2016-09-23
Kobold® Vaginal Cylinder Applicator Set (V) - 705-000
2016-09-23
Kobold® Miami Cylinder Applicator Set (V) - 706-000
2016-09-23
Kobold® SBRT Board - 300-000
2016-09-23
Kobold® Tandem and 30/45/60 Deg Ring Applicator Set (E) - Labelled with CE mark
2019-03-25
Kobold® Tandem and 60 Deg Ring Applicator Set (E) - Labelled with CE mark
2019-03-25
Kobold® Tandem and 45 Deg Ring Applicator Set (E) - Labelled with CE mark
2019-03-25
Kobold® Tandem and 30 Deg Ring Applicator Set (E) - Labelled with CE mark
2019-03-25
Kobold® Tandem and 30/45/60 Deg Ring Applicator Set (E) - 707-001
2016-09-23
Kobold® Tandem and 60 Deg Ring Applicator Set (E) - 707-002
2016-09-23
Kobold® Tandem and 45 Deg Ring Applicator Set (E) - 707-003
2016-09-23
Kobold® Tandem and 30 Deg Ring Applicator Set (E) - 707-004
2016-09-23