Cleared Traditional

Synchrony (20-3000)

K242704 · Synapse Biomedical, Inc. · Neurology
Jun 2025
Decision
269d
Days
Class 2
Risk

About This 510(k) Submission

K242704 is an FDA 510(k) clearance for the Synchrony (20-3000), a Stimulator, Neuromuscular, External Functional (Class II — Special Controls, product code GZI), submitted by Synapse Biomedical, Inc. (Oberline, US). The FDA issued a Cleared decision on June 5, 2025, 269 days after receiving the submission on September 9, 2024. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5810.

Submission Details

510(k) Number K242704 FDA.gov
FDA Decision Cleared SESE
Date Received September 09, 2024
Decision Date June 05, 2025
Days to Decision 269 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GZI — Stimulator, Neuromuscular, External Functional
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5810