Cleared Traditional

K982819 - ENDIUS SPINE ENDOSCOPE

K982819 is an FDA 510(k) clearance for ENDIUS SPINE ENDOSCOPE, manufactured by Endius, Inc.. The device is a Class 2 Neurology device with product code GWG cleared through the Traditional 510(k) pathway after a 169-day FDA review.

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

FDA 510(k) Submission Details - K982819

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
Combination Product No
PCCP Authorized No
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.

GWG Device Classification - Class 2, Special Controls

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 87
Devices cleared under the same product code (GWG) and FDA review panel - the closest regulatory comparables to K982819.
MITAKA POINT SETTER
K991989 · Mitaka USA, Inc. · Aug 1999
KSEA NEURO-FIBERSCOPE
K991069 · KARL STORZ Endoscopy-America, Inc. · Jun 1999
MEDTRONIC PS MEDICAL INTRODUCER SHEATH 12F,14F,15F, MODELS 3805-012, 3805-014, 3805-015
K990333 · Medtronic PS Medical · Apr 1999
AESCULAP MINOP SYSTEM
K983365 · Aesculap, Inc. · Dec 1998
KSEA GAAB NEUROENDOSCOPE AND CHAVANTES-ZAAMORANO NEUROENDOSCOPE SETS
K982837 · Karl Storz Endoscopy · Nov 1998
OLYMPUS NEURO ENDOSCOPE
K971340 · Olympus Optical, Co. · Jul 1998