Cleared Traditional

K875019 - GHAJAR GUIDE SYSTEM FOR THE PERFORATOR

K875019 is an FDA 510(k) clearance for GHAJAR GUIDE SYSTEM FOR THE PERFORATOR, manufactured by Neurodynamics, Inc.. The device is a Class 2 Neurology device with product code HBF cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K875019 · Neurodynamics, Inc. · Neurology device
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Jan 1988
Decision
49d
Days
Class 2
Risk

K875019 is an FDA 510(k) clearance for the GHAJAR GUIDE SYSTEM FOR THE PERFORATOR. Classified as Drills, Burrs, Trephines & Accessories (compound, Powered) (product code HBF), Class II - Special Controls.

Submitted by Neurodynamics, Inc. (New York, US). The FDA issued a Cleared decision on January 22, 1988 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4305 - 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 Neurodynamics, Inc. devices

FDA 510(k) Submission Details - K875019

510(k) Number K875019 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 1987
Decision Date January 22, 1988
Days to Decision 49 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 148d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HBF Device Classification - Class 2, Special Controls

Product Code HBF Drills, Burrs, Trephines & Accessories (compound, Powered)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4305
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 - HBF Drills, Burrs, Trephines & Accessories (compound, Powered)

All 14
Devices cleared under the same product code (HBF) and FDA review panel - the closest regulatory comparables to K875019.
ANSPACH ACCESS CRANIAL PERFORATOR
K982991 · The Anspach Effort, Inc. · Oct 1998
DISPOSABLE PERFORATOR
K933894 · Codman & Shurtleff, Inc. · Dec 1993
DISPOSABLE PERFORATOR
K924242 · Codman & Shurtleff, Inc. · Jul 1993
CODMAN * REUSABLE PERFORATOR
K820087 · Codman & Shurtleff, Inc. · Feb 1982
DISPOSABLE PERFORATORS, JACOBS, HUDSON
K791101 · Codman & Shurtleff, Inc. · Aug 1979