Cleared Traditional

K131304 - SENTIO MMG

K131304 is an FDA 510(k) clearance for SENTIO MMG, manufactured by Innovative Surgical Solutions, LLC ("Iss"). The device is a Class 2 Neurology device with product code PDQ cleared through the Traditional 510(k) pathway after a 387-day FDA review.

K131304 · Innovative Surgical Solutions, LLC ("Iss") · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2014
Decision
387d
Days
Class 2
Risk

K131304 is an FDA 510(k) clearance for the SENTIO MMG. Classified as Neurosurgical Nerve Locator (product code PDQ), Class II - Special Controls.

Submitted by Innovative Surgical Solutions, LLC ("Iss") (Southfield, US). The FDA issued a Cleared decision on May 29, 2014 after a review of 387 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 874.1820 - 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. Elevated predicate reliance profile. 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 Innovative Surgical Solutions, LLC ("Iss") devices

FDA 510(k) Submission Details - K131304

510(k) Number K131304 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 2013
Decision Date May 29, 2014
Days to Decision 387 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
239d slower than avg
Panel avg: 148d · This submission: 387d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PDQ Device Classification - Class 2, Special Controls

Product Code PDQ Neurosurgical Nerve Locator
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.1820
Definition To Locate Or Monitor Function Of Spinal Nerve Roots Or Peripheral Nerves During Neurosurgery.
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 - PDQ Neurosurgical Nerve Locator

All 24
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