Stockert Neuro N50, MODEL12267

FDA 510(k) K070336 · Stockert GmbH

Substantially Equivalent

510(k) numberK070336

Submission

Device name
Stockert Neuro N50, MODEL12267
Applicant
Stockert GmbH
Freiburg, B-W, DE
Received
February 5, 2007
Decision date
June 14, 2007
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary 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
K070134Modification to Stimuplex HNS-12, Model 4892098BXN · Special 03/22/2007SE
K061983Stimuplex PenBXN · Abbreviated 11/21/2006SE
K052313Stimuplex HNS-12, Model 4892098BXN · Abbreviated 11/17/2005SE
K003983Stimuplex HNS-11BXN · Traditional 06/06/2001SE

Questions and answers

When was Stockert Neuro N50, MODEL12267 cleared by the FDA?

Stockert Neuro N50, MODEL12267 (K070336) received a 510(k) decision of Substantially Equivalent on June 14, 2007, 129 days after the submission was received.

What is the product code of K070336?

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