Cleared Traditional

K014149 - PAEDISCOPE

K014149 is the FDA 510(k) clearance for PAEDISCOPE by Aesculap, Inc.. It is a Class 2 Neurology device (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

Submission Details

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.

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 53
Devices cleared under the same product code (GWG) and FDA review panel - the closest regulatory comparables to K014149.
ENDOSCOPE SET FOR MAGNETIC RESONANCE (MR), MODELS 8767.412, 8767.121 & 8767.452
K022198 · Richard Wolf Medical Instruments Corp. · Mar 2003
OLYMPUS NEUROSCOPE, MODELS S-1349/1, S-1349/2, S-1349/3 AND S-1349/4
K020507 · Olympus Winter & Ibe GmbH · Oct 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
KSEA BIPOLAR COAGULATING ELECTRODES
K001630 · Karl Storz Endoscopy · Jul 2000