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Depth Electrode - Depth Electrode (RSDE-12)

by Beijing Sinovation Medical Technology Co., Ltd.

510(k) K250363

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 · Traditional NumberK250363 Date5 Nov 2025ClearedStatusActive

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  • Withdrawn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
GZL
Models / Variants
Depth Electrode (RSDE-12)
Device Class
Class II
Regulation
21 CFR Part 882.1330
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 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 Depth Electrode is a medical device classified as an electrode designed for neurological applications. It is used to facilitate electrical monitoring or stimulation within the brain.

This device is available in multiple configurations, including models RSDE-08, RSDE-10, RSDE-12, RSDE-14, RSDE-16, RSDE-16F, RSDE-08S, RSDE-10S, RSDE-12S, RSDE-14S, RSDE-16S, RSDE-16G, RSDE-18, RSDE-18F, RSDE-18T, RSDE-20, and RSDE-20F. The product has received FDA 510(k) clearance under regulation number 882.1330.

Questions

AI-generated answers, 23 Sep 2026

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

  • What is the primary clinical application of the Depth Electrode?

    The Depth Electrode is designed specifically for neurological applications. It is used to facilitate electrical monitoring or stimulation directly within the brain.

  • Which models are available for this electrode series?

    The series includes a wide range of configurations to suit different clinical needs, including models RSDE-08, RSDE-10, RSDE-12, RSDE-14, RSDE-16, RSDE-16F, RSDE-08S, RSDE-10S, RSDE-12S, RSDE-14S, RSDE-16S, RSDE-16G, RSDE-18, RSDE-18F, RSDE-18T, RSDE-20, and RSDE-20F.

  • What is the regulatory status of these electrodes?

    These devices have received FDA 510(k) clearance under regulation number 882.1330. This indicates that the device has been reviewed and found to be substantially equivalent to legally marketed predicate devices.