NT-1000

FDA 510(k) K052878 · Neuro Therm, Inc.

Substantially Equivalent

510(k) numberK052878

Submission

Device name
NT-1000
Applicant
Neuro Therm, Inc.
Middleton, MA, US
Received
October 12, 2005
Decision date
January 23, 2006
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
GXD – Generator, Lesion, Radiofrequency
Device class
Class II (moderate risk)
Regulation
21 CFR 882.4400
Specialty
Neurology

Other 510(k)s with product code GXD

510(k)DeviceApplicantDecision
K251247GX1 Radiofrequency Generator Kit (RFG-X1-120V); GX1 Radiofrequency Generator Kit…GXD · Traditional Boston Scientific Neuromodulation Corporation08/07/2025SE
K242057COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R)GXD · Special Avanos Medical, Inc.08/14/2024SE
K232632Racz Neurostat RF GeneratorGXD · Traditional Epimed International05/24/2024SE
K231675OneRF Ablation SystemGXD · Traditional Neuroone Medical Technologies Corp.12/06/2023SE
K220122Apex 6GXD · Traditional Rf Innovations, Inc.03/15/2023SE
K203293Abbott Medical Grounding Pad, model RF-DGP-ISGXD · Traditional Abbott Medical01/21/2022SE
K201610IonicRF GeneratorGXD · Traditional Abbott Medical10/21/2020SE
K192491Coolief Radiofrequency Generator (CRG) SystemGXD · Traditional Avanos Medical, Inc.02/21/2020SE
K181864Polaris RF Ablation SystemGXD · Traditional Baylis Medical Company, Inc.01/02/2019SE
K171143Relievant Medsystems RF GeneratorGXD · Traditional Relievant Medsystems08/18/2017SE

More from Relievant Medsystems

510(k)DeviceDecision
K122503Parallax Balloon Inflatable Bone TAMP-10 MM Balloon Parallax Balloon Inflatable Bone…NDN · Traditional 06/25/2013SE
K111576NT 2000 Lesioning GeneratorGXD · Traditional 09/20/2011SE

Questions and answers

When was NT-1000 cleared by the FDA?

NT-1000 (K052878) received a 510(k) decision of Substantially Equivalent on January 23, 2006, 103 days after the submission was received.

What is the product code of K052878?

The FDA product code is GXD – Generator, Lesion, Radiofrequency, a Class II (moderate risk) device regulated under 21 CFR 882.4400.