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510(k) K050194

AXON SYSTEMS SUBDERMAL NEEDLE ELECTRODES by Axon Systems, Inc. — Product Code GXZ

K050194 is an FDA 510(k) premarket notification submitted by Axon Systems, Inc. for the device "AXON SYSTEMS SUBDERMAL NEEDLE ELECTRODES". The FDA issued a decision of Substantially Equivalent on April 26, 2005. The device falls under product code GXZ (Electrode, Needle), a Class II device regulated under 21 CFR 882.1350. Axon Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 26, 2005
Date Received
January 27, 2005
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 Axon Systems, Inc.

  • K090838 — STIMULUS/DISSECTION INSTRUMENTS (July 20, 2009)
  • K062996 — DISPOSABLE MONOPOLAR AND BIPOLAR STIMULATOR PROBES (January 12, 2007)
  • K062198 — SUNSPOTS PRE-GELLED SURFACE ELECTRODES (December 19, 2006)
  • K061639 — ECLIPSE TCD NEUROVASCULAR WORKSTATION; ELCLIPSE NEUROLOGICAL WORKSTATION WITH TC (November 1, 2006)
  • K061113 — ORTHOMON (May 23, 2006)
  • K050798 — ECLIPSE NEUROLOGICAL WORKSTATION (August 15, 2005)
  • K032741 — EPOCHXP NEUROLOGICAL WORKSTATION,EPOCHXP LITE NEUROLOGICAL WORKSTATION (December 16, 2003)
  • K022785 — EPOCH XP NEUROLOGICAL WORKSTATION; EPOCH XP LITE NEUROLOGICAL WORKSTATION (October 9, 2002)
  • K010697 — UNIQUE AMBULATORY EEG (June 6, 2001)
  • K002316 — PHOENIX DIGITAL EEG (October 26, 2000)

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)
  • K140200 — E-SHIELD MULTI-PAIRED SUBDERMAL NEEDLE ELECTRODES (July 18, 2014)
  • K130220 — MR CONDITIONAL PRESSON ELECTRODE (July 22, 2013)

FDA data resources