Cleared Traditional

K071931 - CODMAN DISPOSABLE PERFORATOR

K071931 is the FDA 510(k) clearance for CODMAN DISPOSABLE PERFORATOR by Codman & Shurtleff, Inc.. It is a Class 2 Neurology device (product code HBF) cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K071931 · Codman & Shurtleff, Inc. · Neurology device
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Oct 2007
Decision
101d
Days
Class 2
Risk

K071931 is an FDA 510(k) clearance for the CODMAN DISPOSABLE PERFORATOR, MODEL(S) 26-1222, 26-1223. Classified as Drills, Burrs, Trephines & Accessories (compound, Powered) (product code HBF), Class II - Special Controls.

Submitted by Codman & Shurtleff, Inc. (Raynham, US). The FDA issued a Cleared decision on October 22, 2007 after a review of 101 days - within the typical 510(k) review window.

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: 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 K071931 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 2007
Decision Date October 22, 2007
Days to Decision 101 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 148d · This submission: 101d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 10
Devices cleared under the same product code (HBF) and FDA review panel - the closest regulatory comparables to K071931.
Codman Disposable Perforators
K183581 · Integra Lifesciences Corp. · Jan 2019
CRANIAL PERFORATOR
K082637 · The Anspach Effort, Inc. · Dec 2008
CODMAN CRANIOTOMY KIT, MODELS 26-1229, 26-1230, 26-1231
K073336 · Codman & Shurtleff, Inc. · Jan 2008
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