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510(k) K050325

DISPOSABLE CONCENTRIC PROBE, DISPOSABLE BIPOLAR PROBE, DISPOSABLE MONOPOLAR PROBE by Technomed Europe — Product Code GXZ

K050325 is an FDA 510(k) premarket notification submitted by Technomed Europe for the device "DISPOSABLE CONCENTRIC PROBE, DISPOSABLE BIPOLAR PROBE, DISPOSABLE MONOPOLAR PROBE". The FDA issued a decision of Substantially Equivalent on May 5, 2005. The device falls under product code GXZ (Electrode, Needle), a Class II device regulated under 21 CFR 882.1350. Technomed Europe has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 5, 2005
Date Received
February 9, 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 Technomed Europe

  • K254183 — MR Conditional Cup Electrodes (May 7, 2026)
  • K253581 — Disposable Concentric Needle Electrode 0.30x25mm Red (TE/B50700-001); Disposable (March 15, 2026)
  • K241045 — Disposable Subdermal Needle Electrode, Corkscrew (December 11, 2024)
  • K130136 — DISPOSABLE AND REUSABLE CONCENTRIC NEEDLE ELECTRODES,DISPOSABLE AND REUSABLE SUB (July 19, 2013)
  • K121257 — LARYNGEAL ELECTRODE (August 28, 2012)
  • K110422 — SURGICAL STIMULATORS (May 26, 2011)
  • K073532 — DISPOSABLE ADHESIVE SURFACE ELECTRODES, DISC ELECTRODES (May 1, 2008)
  • K072016 — CUP ELECTRODES, GOLD, REUSABLE, SILVER, REUSABLE; CUP ELECTRODES SILVER/SILVER C (October 19, 2007)
  • K063729 — DISPOSABLE PEDICLE SCREW PROBE, MODEL 3603-00 (August 21, 2007)
  • K062437 — DISPOSABLE HYPODERMIC EMG NEEDLE ELECTRODE TECHNOMED EUROPE VERSION AND PRIVATE (February 16, 2007)

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