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510(k) K140200

E-SHIELD MULTI-PAIRED SUBDERMAL NEEDLE ELECTRODES by Neuroinvent, Inc. — Product Code GXZ

K140200 is an FDA 510(k) premarket notification submitted by Neuroinvent, Inc. for the device "E-SHIELD MULTI-PAIRED SUBDERMAL NEEDLE ELECTRODES". The FDA issued a decision of Substantially Equivalent on July 18, 2014. The device falls under product code GXZ (Electrode, Needle), a Class II device regulated under 21 CFR 882.1350. Neuroinvent, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 2014
Date Received
January 27, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Needle
Device Class
Class II
Regulation Number
882.1350
Review Panel
NE
Submission Type

Other clearances by Neuroinvent, Inc.

  • K142470 — E-Shield Multi-paried Subdermal Needle Electrodes (November 5, 2014)

Other clearances for product code GXZ

  • K241045 — Disposable Subdermal Needle Electrode, Corkscrew (December 11, 2024)
  • K232581 — Medical Disposable Sterile Needle Electrode (December 4, 2023)
  • K231691 — Phantom XL Insulated Dilators (June 29, 2023)
  • K200984 — Guardian Needle Electrode (May 27, 2020)
  • K192603 — Spes Medica Subdermal Needle Electrodes (November 22, 2019)
  • K190801 — PressOn Electrode Headset (July 10, 2019)
  • K161566 — DMS Disposable Subdermal Needle Electrodes (December 21, 2016)
  • K142470 — E-Shield Multi-paried Subdermal Needle Electrodes (November 5, 2014)
  • K130220 — MR CONDITIONAL PRESSON ELECTRODE (July 22, 2013)
  • K130136 — DISPOSABLE AND REUSABLE CONCENTRIC NEEDLE ELECTRODES,DISPOSABLE AND REUSABLE SUB (July 19, 2013)

FDA data resources