Cleared Traditional

K911723 - CODMAN DISPOSABLE SKULL PINS

K911723 is the FDA 510(k) clearance for CODMAN DISPOSABLE SKULL PINS by Codman & Shurtleff, Inc.. It is a Class 2 Neurology device (product code HBL) cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K911723 · Codman & Shurtleff, Inc. · Neurology device
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Sep 1991
Decision
146d
Days
Class 2
Risk

K911723 is an FDA 510(k) clearance for the CODMAN DISPOSABLE SKULL PINS. Classified as Holder, Head, Neurosurgical (skull Clamp) (product code HBL), Class II - Special Controls.

Submitted by Codman & Shurtleff, Inc. (Randolph, US). The FDA issued a Cleared decision on September 10, 1991 after a review of 146 days - within the typical 510(k) review window.

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 Codman & Shurtleff, Inc. devices

Submission Details

510(k) Number K911723 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 1991
Decision Date September 10, 1991
Days to Decision 146 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 148d · This submission: 146d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 21
Devices cleared under the same product code (HBL) and FDA review panel - the closest regulatory comparables to K911723.
MAYFIELD RADIOLUCENT DISPOSABLE SKULL PINS
K071458 · Integra LifeSciences Corporation · Jun 2007
MODIFICATION TO: MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2020
K053045 · Integra LifeSciences Corporation · Nov 2005
CODMAN SKULL PINS (ADULT & CHILD), REUSABLE
K912005 · Codman & Shurtleff, Inc. · Sep 1991
CODMAN SKULL CLAMP
K913170 · Codman & Shurtleff, Inc. · Sep 1991
GARDNER PINS (ADULT & CHILD)
K911772 · Codman & Shurtleff, Inc. · Aug 1991
CODMAN SKULL CLAMP
K912011 · Codman & Shurtleff, Inc. · Jul 1991