Cleared Traditional

K250363 - Depth Electrode (RSDE-08)

Also marketed or referenced as:
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

K250363 is an FDA 510(k) clearance for Depth Electrode (RSDE-08), manufactured by Beijing Sinovation Medical Technology Co., Ltd.. The device is a Class 2 Neurology device with product code GZL cleared through the Traditional 510(k) pathway after a 268-day FDA review.

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

FDA 510(k) Submission Details - K250363

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.

GZL Device Classification - Class 2, Special Controls

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 16
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