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510(k) K052111

XLTEK CLEAR SIGNAL SUB-DERMAL NEEDLE, MODELS 102889, 102798, 102799, 102382 by Excel Tech. , Ltd. — Product Code GXZ

K052111 is an FDA 510(k) premarket notification submitted by Excel Tech. , Ltd. for the device "XLTEK CLEAR SIGNAL SUB-DERMAL NEEDLE, MODELS 102889, 102798, 102799, 102382". The FDA issued a decision of Substantially Equivalent on August 17, 2005. The device falls under product code GXZ (Electrode, Needle), a Class II device regulated under 21 CFR 882.1350. Excel Tech. , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 17, 2005
Date Received
August 4, 2005
Clearance Type
Abbreviated
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 Excel Tech. , Ltd.

  • K062549 — XLTEK STIMULATOR PROBES, MODELS 105233, 105234, 105235, 105236, 105237 AND 10523 (October 4, 2006)
  • K061269 — XLTEK CLEAN SIGNAL ADHESIVE ELECTRODES (August 14, 2006)
  • K053386 — XLTEK EMU40 EEG HEADBOX, MODEL PK1072 (April 21, 2006)
  • K053058 — XLTEK NEUROPATH, MODEL PK1070 (February 7, 2006)
  • K052112 — XLTEK XCALIBUR EMG / LT, MODEL PK1P33, PK1059 (October 28, 2005)
  • K042223 — XLTEK CONNEX IP HEADBOX, MODEL 1054 (September 16, 2004)
  • K042150 — XLTEK TREX MODEL#10309 (August 27, 2004)
  • K040358 — XLTEK PROTEKTOR STIMULATOR, MODELS 10247 & 10248 (August 6, 2004)
  • K040360 — EMU128S, MODEL EX-NW-128S (March 12, 2004)
  • K022037 — XLTEK SLEEP SYSTEM (September 10, 2002)

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