Skip to content

XLTEK Clear Signal Sub-Dermal Needle, Models 102889, 102798, 102799, 102382

by Excel Tech., Ltd.

510(k) K052111

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Abbreviated NumberK052111 Date17 Aug 2005ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
GXZ
Models / Variants
FDA applicant
Excel Tech. , Ltd.
Device Class
Class II
Regulation
21 CFR Part 882.1350
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The XLTEK Clear Signal Sub-Dermal Needle is a needle electrode classified under Electrode, Needle. It is designed for use with recording, monitoring, and stimulation equipment to capture biopotential signals, including those used in electromyography (EMG), electroencephalography (EEG), and nerve potential recordings.

The device is supplied sterile and is intended for single-patient use only. It is classified as a Class II medical device under regulation 882.1350 and was reviewed under the FDA 510(k) process with clearance type Abbreviated. The product code is GXZ, and the review panel and medical specialty are both listed as Neurology.

Other devices from Excel Tech., Ltd.

See all devices from Excel Tech., Ltd. →