Generator, Lesion, Radiofrequency

Product Code: GXD

Neurology Microwave Medical Products

Definition: Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Co

Applicable Standards: No Standard Applicable. General Radiological Health Requirements Apply. [1000-1005]

Code of Federal Regulations: 882.4400


Radiation TypeMicrowave EMF
Radition SafetyAbbreviated
Annual ReportsNo

Products Classified as GXD

3656Generator, Lesion, RadiofrequencyRadiofrequency Lesion Generator.

Total Product Life Cycle (TPLC) Devices

3656Generator, Lesion, RadiofrequencyRadiofrequency Lesion Generator.

Pre-market Notifications for GXD

K203293Abbott Medical Grounding Pad, Model RF-DGP-ISAbbott Medical
K201610IonicRF GeneratorAbbott Medical
K192491Coolief Radiofrequency Generator (CRG) SystemAvanos Medical, Inc.
K181864Polaris RF Ablation SystemBaylis Medical Company Inc.
K171143Relievant Medsystems RF GeneratorRelievant Medsystems
K170242MultiGen™ 2 RF Generator SystemSTRYKER CORPORATION
K111576NT 2000 LESIONING GENERATORNEUROTHERM, INC.
K093185OWL UNIVERSAL RF SYSTEM URF-3AP (ML)DIROS TECHNOLOGY, INC.
K082051COSMAN G4 RADIOFREQUENCY GENERATOR, MODEL RFG-4COSMAN MEDICAL, INC.
K081729MODIFICATION TO GFX NERVE ABLATION SYSTEMBIOFORM MEDICAL, INC.
K071482STRYKER RF MULTI-LESION GENERATOR, MODEL 0406-900-000SYNERGETICS, INC
K070336STOCKERT NEURO N50, MODEL12267STOCKERT GMBH
K063753GFX NERVE ABLATION SYSTEMACI, INC.
K063489STRYKER INTRADISCAL RF GENERATORSYNERGETICS, INC.
K062758OWL URF-3APDIROS TECHNOLOGY, INC.

Global Unique Device Identification Database

00813250017991GENERATOR, LESION, RADIOFREQUENCY
00813250017793GENERATOR, LESION, RADIOFREQUENCY
00813250017786GENERATOR, LESION, RADIOFREQUENCY
00813250017670GENERATOR, LESION, RADIOFREQUENCY
00813250017588GENERATOR, LESION, RADIOFREQUENCY
00813250017571GENERATOR, LESION, RADIOFREQUENCY
00813250017533GENERATOR, LESION, RADIOFREQUENCY
00813250017519GENERATOR, LESION, RADIOFREQUENCY
00813250017441GENERATOR, LESION, RADIOFREQUENCY
00813250017342GENERATOR, LESION, RADIOFREQUENCY
00813250017311GENERATOR, LESION, RADIOFREQUENCY
00813250017281GENERATOR, LESION, RADIOFREQUENCY
00813250017243GENERATOR, LESION, RADIOFREQUENCY
00813250017229GENERATOR, LESION, RADIOFREQUENCY
00813250017069GENERATOR, LESION, RADIOFREQUENCY

Maude Adverse Events

NT1000 PAIN MANAGEMENT RF GENERATORNEUROTHERM, INC2020-03-26
4 LESION NT2000? PAIN MANAGEMENT RF GENERATORST. JUDE MEDICAL, INC.2020-03-26
RF DISPOSABLE GROUNDING PADNEUROTHERM, INC2020-03-17
3 LESION NT1100? PAIN MANAGEMENT RF GENERATORNEUROTHERM, INC2020-03-13
4 LESION NT2000? PAIN MANAGEMENT RF GENERATORST. JUDE MEDICAL, INC.2020-03-11
PAIN MANAGEMENT GENERATOR, VERSION 4.1.1, ADVANCEDAVANOS MEDICAL INC.2020-03-10
4 LESION NT2000? PAIN MANAGEMENT RF GENERATORNEUROTHERM, INC2020-03-10
4 LESION NT2000? PAIN MANAGEMENT RF GENERATORST. JUDE MEDICAL, INC.2020-03-06
4 LESION NT2000? PAIN MANAGEMENT RF GENERATORST. JUDE MEDICAL, INC.2020-03-05
AMPERE? RF ABLATION GENERATORST. JUDE MEDICAL, INC.2020-03-05
AMPERE? RF ABLATION GENERATORST. JUDE MEDICAL, INC.2020-03-02
3 LESION NT1100? PAIN MANAGEMENT RF GENERATORNEUROTHERM, INC2020-02-28
AMPERE? RF ABLATION GENERATORST. JUDE MEDICAL, INC.2020-02-20
ACCURIANMEDTRONIC, INC.2020-02-18
ACCURIANRICE CREEK MFG2020-02-18
MULTIGEN RADIOFREQUENCY GENERATORSTRYKER INSTRUMENTS-KALAMAZOO2020-02-14
ACCURIANMEDTRONIC NEUROMODULATION2020-02-14
REUSABLE ELECTRODE, 10CM, NITINOLNEUROTHERM, INC2020-02-12
4 LESION NT2000? PAIN MANAGEMENT RF GENERATORNEUROTHERM, INC2020-02-11
AMPERE? RF ABLATION GENERATORST. JUDE MEDICAL, INC.2020-02-10
4 LESION NT2000? PAIN MANAGEMENT RF GENERATORST. JUDE MEDICAL, INC.2020-02-07
NT1000 PAIN MANAGEMENT RF GENERATORST. JUDE MEDICAL, INC.2020-02-07
4 LESION NT2000? PAIN MANAGEMENT RF GENERATORST. JUDE MEDICAL, INC.2020-02-05
3 LESION NT1100? PAIN MANAGEMENT RF GENERATORNEUROTHERM, INC2020-02-04
FAST-CATH? TRANSSEPTAL GUIDING INTRODUCERST. JUDE MEDICAL2020-01-31
4 LESION NT2000? PAIN MANAGEMENT RF GENERATORNEUROTHERM, INC2020-01-30
3 LESION NT1100? PAIN MANAGEMENT RF GENERATORST. JUDE MEDICAL, INC.2020-01-29
4 LESION NT2000? PAIN MANAGEMENT RF GENERATORST. JUDE MEDICAL, INC.2020-01-28
3 LESION NT1100? PAIN MANAGEMENT RF GENERATORNEUROTHERM, INC2020-01-28
4 LESION NT2000? PAIN MANAGEMENT RF GENERATORNEUROTHERM, INC2020-01-22
3 LESION NT1100? PAIN MANAGEMENT RF GENERATORST. JUDE MEDICAL, INC.2020-01-21
4 LESION NT2000? PAIN MANAGEMENT RF GENERATORST. JUDE MEDICAL, INC.2020-01-17
4 LESION NT2000? PAIN MANAGEMENT RF GENERATORST. JUDE MEDICAL, INC.2020-01-16
NEUROTHERM NT2000IX 230V 3.1ST. JUDE MEDICAL, INC.2020-01-16
AMPERE? RF ABLATION GENERATORST. JUDE MEDICAL, INC.2020-01-10
3 LESION NT1100? PAIN MANAGEMENT RF GENERATORNEUROTHERM, INC2020-01-10
3 LESION NT1100? PAIN MANAGEMENT RF GENERATORNEUROTHERM, INC2020-01-10
BOSTON SCIENTIFIC NEUROMODULATION2020-01-08
4 LESION NT2000? PAIN MANAGEMENT RF GENERATORNEUROTHERM, INC2020-01-06
3 LESION NT1100? PAIN MANAGEMENT RF GENERATORNEUROTHERM, INC2019-11-27
4 LESION NT2000? PAIN MANAGEMENT RF GENERATORNEUROTHERM, INC2019-11-25
4 LESION NT2000? PAIN MANAGEMENT RF GENERATORST. JUDE MEDICAL, INC.2019-11-25
4 LESION NT2000? PAIN MANAGEMENT RF GENERATORST. JUDE MEDICAL, INC.2019-11-19
4 LESION NT2000? PAIN MANAGEMENT RF GENERATORST. JUDE MEDICAL, INC.2019-11-15
AMPERE? RF ABLATION GENERATORST. JUDE MEDICAL, INC.2019-11-15
AMPERE? RF GENERATOR IIST. JUDE MEDICAL, INC.2019-11-14
4 LESION NT2000? PAIN MANAGEMENT RF GENERATORST. JUDE MEDICAL, INC.2019-11-13
DISPOSABLE GROUNDING PAD W/CABLEST. JUDE MEDICAL, INC.2019-11-12
3 LESION NT1100? PAIN MANAGEMENT RF GENERATORST. JUDE MEDICAL, INC.2019-11-08
4 LESION NT2000? PAIN MANAGEMENT RF GENERATORST. JUDE MEDICAL, INC.2019-11-06
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