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510(k) K070336

STOCKERT NEURO N50, MODEL12267 by Stockert GmbH — Product Code GXD

K070336 is an FDA 510(k) premarket notification submitted by Stockert GmbH for the device "STOCKERT NEURO N50, MODEL12267". The FDA issued a decision of Substantially Equivalent on June 14, 2007. The device falls under product code GXD (Generator, Lesion, Radiofrequency), a Class II device regulated under 21 CFR 882.4400. Stockert GmbH has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 2007
Date Received
February 5, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Generator, Lesion, Radiofrequency
Device Class
Class II
Regulation Number
882.4400
Review Panel
NE
Submission Type

Other clearances by Stockert GmbH

  • K070134 — MODIFICATION TO STIMUPLEX HNS-12, MODEL 4892098 (March 22, 2007)
  • K061983 — STIMUPLEX PEN (November 21, 2006)
  • K052313 — STIMUPLEX HNS-12, MODEL 4892098 (November 17, 2005)
  • K003983 — STIMUPLEX HNS-11 (June 6, 2001)

Other clearances for product code GXD

  • K251247 — GX1 Radiofrequency Generator Kit (RFG-X1-120V); GX1 Radiofrequency Generator Kit (August 7, 2025)
  • K242057 — COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADV (August 14, 2024)
  • K232632 — Racz Neurostat RF Generator (May 24, 2024)
  • K231675 — OneRF Ablation System (December 6, 2023)
  • K220122 — APEX 6 (March 15, 2023)
  • K203293 — Abbott Medical Grounding Pad, model RF-DGP-IS (January 21, 2022)
  • K201610 — IonicRF Generator (October 21, 2020)
  • K192491 — Coolief Radiofrequency Generator (CRG) System (February 21, 2020)
  • K181864 — Polaris RF Ablation System (January 2, 2019)
  • K171143 — Relievant Medsystems RF Generator (August 18, 2017)

FDA data resources