Cleared Special

K083378 - SYNERGY

K083378 is an FDA 510(k) clearance for SYNERGY, manufactured by Innerspace, Inc.. The device is a Class 2 Neurology device with product code GWM cleared through the Special 510(k) pathway after a 319-day FDA review.

K083378 · Innerspace, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K083378

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
170d slower than avg
Panel avg: 149d · This submission: 319d
Pathway characteristics
Modification to existing cleared device.

GWM Device Classification - Class 2, Special Controls

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 90
Devices cleared under the same product code (GWM) and FDA review panel - the closest regulatory comparables to K083378.
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K071984 · Cma Microdialysis AB · Jun 2008
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K072379 · Innerspace, Inc. · Apr 2008
MODIFICATION TO NEUROSENSOR CEREBRAL BLOOD FLOW AND INTRACRANIAL PRESSURE MONITORING SYSTEM
K071505 · Integra LifeSciences Corporation · Aug 2007
K083378 · SYNERGY
Download PDF FDA Summary Innerspace, Inc.