Cleared Traditional

K911772 - GARDNER PINS (ADULT & CHILD)

K911772 is the FDA 510(k) clearance for GARDNER PINS (ADULT & CHILD) by Codman & Shurtleff, Inc.. It is a Class 2 Neurology device (product code HBL) cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K911772 · Codman & Shurtleff, Inc. · Neurology device
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Aug 1991
Decision
129d
Days
Class 2
Risk

K911772 is an FDA 510(k) clearance for the GARDNER PINS (ADULT & CHILD). 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 August 26, 1991 after a review of 129 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 K911772 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 1991
Decision Date August 26, 1991
Days to Decision 129 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
19d faster than avg
Panel avg: 148d · This submission: 129d
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 K911772.
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
CODMAN SKULL CLAMP
K912011 · Codman & Shurtleff, Inc. · Jul 1991
SURGITA/MIZHO MICRONEUROSURGERY HEAD FR
K821772 · Downs Surgical , Ltd. · Sep 1982