Cleared Traditional

K925881 - DISPOSABLE BIOPSY FORCEP

K925881 is an FDA 510(k) clearance for DISPOSABLE BIOPSY FORCEP, manufactured by Neuro Navigational Corp.. The device is a Class 2 Neurology device with product code GWG cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K925881 · Neuro Navigational Corp. · Neurology device
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Feb 1993
Decision
92d
Days
Class 2
Risk

K925881 is an FDA 510(k) clearance for the DISPOSABLE BIOPSY FORCEP. Classified as Endoscope, Neurological (product code GWG), Class II - Special Controls.

Submitted by Neuro Navigational Corp. (Costa Mesa, US). The FDA issued a Cleared decision on February 19, 1993 after a review of 92 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 Neuro Navigational Corp. devices

FDA 510(k) Submission Details - K925881

510(k) Number K925881 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1992
Decision Date February 19, 1993
Days to Decision 92 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
56d faster than avg
Panel avg: 148d · This submission: 92d
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 68
Devices cleared under the same product code (GWG) and FDA review panel - the closest regulatory comparables to K925881.
CODMAN LASER NEUROENDOSCOPE
K924977 · Codman & Shurtleff, Inc. · Nov 1993
DISPOSABLE PEEL-AWAY INTRODUCER SHEATH
K931973 · Neuro Navigational Corp. · Sep 1993
DISPOSABLE GRASPING FORCEP
K933244 · Neuro Navigational Corp. · Sep 1993
CODMAN ENDOFLEX GRASPING AND BIOPSY FORCEPS
K923646 · Codman & Shurtleff, Inc. · Dec 1992