Cleared Traditional

K250363 - Depth Electrode (RSDE-08) (FDA 510(k) Clearance)

Also includes:
Depth Electrode (RSDE-10) Depth Electrode (RSDE-12) Depth Electrode (RSDE-14) Depth Electrode (RSDE-16) Depth Electrode (RSDE-16F) Depth Electrode (RSDE-08S) Depth Electrode (RSDE-10S) Depth Electrode (RSDE-12S) Depth Electrode (RSDE-14S) Depth Electrode (RSDE-16S) Depth Electrode (RSDE-16G) Depth Electrode (RSDE-18) Depth Electrode (RSDE-18F) Depth Electrode (RSDE-18T) Depth Electrode (RSDE-20) Depth Electrode (RSDE-20F) Dept

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K250363 · Beijing Sinovation Medical Technology Co., Ltd. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2025
Decision
268d
Days
Class 2
Risk

K250363 is an FDA 510(k) clearance for the Depth Electrode (RSDE-08). Classified as Electrode, Depth (product code GZL), Class II - Special Controls.

Submitted by Beijing Sinovation Medical Technology Co., Ltd. (Beijing, CN). The FDA issued a Cleared decision on November 5, 2025 after a review of 268 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1330 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Beijing Sinovation Medical Technology Co., Ltd. devices

Submission Details

510(k) Number K250363 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 2025
Decision Date November 05, 2025
Days to Decision 268 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
120d slower than avg
Panel avg: 148d · This submission: 268d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GZL Electrode, Depth
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1330
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - GZL Electrode, Depth

All 57
Devices cleared under the same product code (GZL) and FDA review panel - the closest regulatory comparables to K250363.
Wovyn Depth Electrode
K253970 · Sensomedical Labs, Ltd. · Apr 2026
Neuro Omega System
K250601 · Alpha Omega Engineering , Ltd. · Mar 2025
Spencer Probe Depth Electrodes
K223269 · Ad-Tech Medical Instrument Corporation · May 2023
Anchor Bolts as Accessories to Depth Electrodes
K223276 · Ad-Tech Medical Instrument Corporation · May 2023
SENSOSEEG Depth Electrodes
K213170 · Sensomedical Labs, Ltd. · Apr 2023
iCE-SG2 Subcutaneous Electrode Kit
K222706 · Ice Neurosystems, Inc. · Dec 2022