Cleared Traditional

K982819 - ENDIUS SPINE ENDOSCOPE (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K982819 · Endius, Inc. · Neurology device
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Jan 1999
Decision
169d
Days
Class 2
Risk

K982819 is an FDA 510(k) clearance for the ENDIUS SPINE ENDOSCOPE. Classified as Endoscope, Neurological (product code GWG), Class II - Special Controls.

Submitted by Endius, Inc. (Newton, US). The FDA issued a Cleared decision on January 27, 1999 after a review of 169 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1480 - 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 Endius, Inc. devices

Submission Details

510(k) Number K982819 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 1998
Decision Date January 27, 1999
Days to Decision 169 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d slower than avg
Panel avg: 148d · This submission: 169d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GWG Endoscope, Neurological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1480
Definition If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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 - GWG Endoscope, Neurological

All 90
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