Cleared Special

SYNERGY (K083378) - FDA 510(k) Clearance

Class II Neurology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K083378 · Innerspace, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2009
Decision
319d
Days
Class 2
Risk

K083378 is an FDA 510(k) clearance for the SYNERGY. Classified as Device, Monitoring, Intracranial Pressure (product code GWM), Class II - Special Controls.

Submitted by Innerspace, Inc. (Tustin, US). The FDA issued a Cleared decision on September 29, 2009 after a review of 319 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1620 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Elevated predicate reliance profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Innerspace, Inc. devices

Submission Details

510(k) Number K083378 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 2008
Decision Date September 29, 2009
Days to Decision 319 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
171d slower than avg
Panel avg: 148d · This submission: 319d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code GWM Device, Monitoring, Intracranial Pressure
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1620
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 - GWM Device, Monitoring, Intracranial Pressure

All 104
Devices cleared under the same product code (GWM) and FDA review panel - the closest regulatory comparables to K083378.
Pressio 3 Multi-parameter Neuromonitoring System
K252241 · Sophysa · Apr 2026
NEUROVENT-P (092946-003)
K250285 · Raumedic AG · Aug 2025
B4C System - Addition of new sensor model (BcSs-PICNIW-2000)
K240821 · Braincare Desenvolvimento E Inova??o Tecnol?gica S.A. · Jul 2024
CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845)
K232890 · Integra Lifesciences Production Corporation · Feb 2024
B4C System
K201989 · Braincare Desenvolvimento E Inovacao Tecnologica S.A. · Oct 2021
CereLink ICP Monitor
K210993 · Integra Lifesciences Production Corporation · Apr 2021