Cleared Traditional

K923789 - MAYFIELD ADULT DISPOSABLE SKULL PIN

K923789 is an FDA 510(k) clearance for MAYFIELD ADULT DISPOSABLE SKULL PIN, manufactured by Ohio Medical Instrument Co., Inc.. The device is a Class 2 Neurology device with product code HBL cleared through the Traditional 510(k) pathway after a 199-day FDA review.

K923789 · Ohio Medical Instrument Co., Inc. · Neurology device
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Feb 1993
Decision
199d
Days
Class 2
Risk

K923789 is an FDA 510(k) clearance for the MAYFIELD ADULT DISPOSABLE SKULL PIN. Classified as Holder, Head, Neurosurgical (skull Clamp) (product code HBL), Class II - Special Controls.

Submitted by Ohio Medical Instrument Co., Inc. (Cincinnati, US). The FDA issued a Cleared decision on February 12, 1993 after a review of 199 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4460 - 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 Ohio Medical Instrument Co., Inc. devices

FDA 510(k) Submission Details - K923789

510(k) Number K923789 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 1992
Decision Date February 12, 1993
Days to Decision 199 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
51d slower than avg
Panel avg: 148d · This submission: 199d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HBL Device Classification - Class 2, Special Controls

Product Code HBL Holder, Head, Neurosurgical (skull Clamp)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4460
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 - HBL Holder, Head, Neurosurgical (skull Clamp)

All 33
Devices cleared under the same product code (HBL) and FDA review panel - the closest regulatory comparables to K923789.
MAYFIELD RADIOLUCENT SKULL CLAMP
K934289 · Ohio Medical Instrument Co., Inc. · Jan 1994
MAYFIELD* A-2000 SKULL CLAMP
K932807 · Ohio Medical Instrument Co., Inc. · Sep 1993
MAYFIELD ADULT DISPOSABLE SKULL PIN
K932860 · Ohio Medical Instrument Co., Inc. · Sep 1993
CODMAN SKULL PINS (ADULT & CHILD), REUSABLE
K912005 · Codman & Shurtleff, Inc. · Sep 1991
CODMAN DISPOSABLE SKULL PINS
K911723 · Codman & Shurtleff, Inc. · Sep 1991
CODMAN SKULL CLAMP
K913170 · Codman & Shurtleff, Inc. · Sep 1991