Cleared Traditional

NAVIGUS PEEL AWAY INTRODUCER (K002330) - FDA 510(k) Clearance

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

K002330 · Image-Guided Neurologics, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2000
Decision
78d
Days
Class 2
Risk

K002330 is an FDA 510(k) clearance for the NAVIGUS PEEL AWAY INTRODUCER. Classified as Endoscope, Neurological (product code GWG), Class II - Special Controls.

Submitted by Image-Guided Neurologics, Inc. (Melbourne, US). The FDA issued a Cleared decision on October 18, 2000 after a review of 78 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Image-Guided Neurologics, Inc. devices

Submission Details

510(k) Number K002330 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2000
Decision Date October 18, 2000
Days to Decision 78 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
70d faster than avg
Panel avg: 148d · This submission: 78d
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 40
Devices cleared under the same product code (GWG) and FDA review panel - the closest regulatory comparables to K002330.
PAEDISCOPE, MODEL # P010A AND PF011A
K014149 · Aesculap, Inc. · Mar 2002
KSEA MINIATURE NEUROENDOSCOPE
K002704 · KARL STORZ Endoscopy-America, Inc. · Nov 2000
KSEA NEURO-FIBERSCOPE
K002788 · KARL STORZ Endoscopy-America, Inc. · Oct 2000
DCI ENDOSCOPE
K993539 · KARL STORZ Endoscopy-America, Inc. · Dec 1999
KSEA NEURO-FIBERSCOPE
K991069 · KARL STORZ Endoscopy-America, Inc. · Jun 1999
AESCULAP MINOP SYSTEM
K983365 · Aesculap, Inc. · Dec 1998