Cleared Traditional

K014149 - PAEDISCOPE, MODEL # P010A AND PF011A

K014149 is an FDA 510(k) clearance for PAEDISCOPE, manufactured by Aesculap, Inc.. The device is a Class 2 Neurology device with product code GWG cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K014149 · Aesculap, Inc. · Neurology device
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Mar 2002
Decision
90d
Days
Class 2
Risk

K014149 is an FDA 510(k) clearance for the PAEDISCOPE, MODEL # P010A AND PF011A. Classified as Endoscope, Neurological (product code GWG), Class II - Special Controls.

Submitted by Aesculap, Inc. (Center Valley, US). The FDA issued a Cleared decision on March 18, 2002 after a review of 90 days - within the typical 510(k) review window.

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 Aesculap, Inc. devices

FDA 510(k) Submission Details - K014149

510(k) Number K014149 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 2001
Decision Date March 18, 2002
Days to Decision 90 days
Submission Type Traditional
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
58d faster than avg
Panel avg: 148d · This submission: 90d
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 84
Devices cleared under the same product code (GWG) and FDA review panel - the closest regulatory comparables to K014149.
OLYMPUS NEUROSCOPE, MODELS S-1349/1, S-1349/2, S-1349/3 AND S-1349/4
K020507 · Olympus Winter & Ibe GmbH · Oct 2002
MSS-28CS-301/701 NEEDLESCOPE
K013759 · Olympus Optical Co., Ltd. · Aug 2002
KSEA NEUROENDOSCOPES AND ACCESSORIES
K021050 · KARL STORZ Endoscopy-America, Inc. · Jun 2002
KSEA MINIATURE NEUROENDOSCOPE
K002704 · KARL STORZ Endoscopy-America, Inc. · Nov 2000
KSEA NEURO-FIBERSCOPE
K002788 · KARL STORZ Endoscopy-America, Inc. · Oct 2000
NAVIGUS PEEL AWAY INTRODUCER
K002330 · Image-Guided Neurologics, Inc. · Oct 2000