Cleared Special

K073336 - CODMAN CRANIOTOMY KIT, MODELS 26-1229, 26-1230, 26-1231

K073336 is an FDA 510(k) clearance for CODMAN CRANIOTOMY KIT, manufactured by Codman & Shurtleff, Inc.. The device is a Class 2 Neurology device with product code HBF cleared through the Special 510(k) pathway after a 37-day FDA review.

K073336 · Codman & Shurtleff, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2008
Decision
37d
Days
Class 2
Risk

K073336 is an FDA 510(k) clearance for the CODMAN CRANIOTOMY KIT, MODELS 26-1229, 26-1230, 26-1231. 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 January 4, 2008 after a review of 37 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K073336

510(k) Number K073336 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 2007
Decision Date January 04, 2008
Days to Decision 37 days
Submission Type Special
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
112d faster than avg
Panel avg: 149d · This submission: 37d
Pathway characteristics
Modification to existing cleared device.

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 16
Devices cleared under the same product code (HBF) and FDA review panel - the closest regulatory comparables to K073336.
MERIDIAN CRANIAL PERFORATOR
K121253 · Adeor Medical Technologies GmbH · Jul 2012
STRYKER DISPOSABLE CRANIAL PERFORATOR BIT
K082010 · Stryker Ireland Ltd., Instruments Division · Dec 2008
CRANIAL PERFORATOR
K082637 · The Anspach Effort, Inc. · Dec 2008
CODMAN DISPOSABLE PERFORATOR, MODEL(S) 26-1222, 26-1223
K071931 · Codman & Shurtleff, Inc. · Oct 2007
ACRA-CUT XPRESS 120
K032970 · Acra Cut, Inc. · Dec 2003
ANSPACH ACCESS CRANIAL PERFORATOR
K982991 · The Anspach Effort, Inc. · Oct 1998
K073336 · CODMAN CRANIOTOMY KIT, MODELS 26-1229, 26-1230, 26-1231
Download PDF FDA Summary Codman & Shurtleff, I…