Cleared Traditional

K924242 - DISPOSABLE PERFORATOR

K924242 is the FDA 510(k) clearance for 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 318-day FDA review.

K924242 · Codman & Shurtleff, Inc. · Neurology device
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Jul 1993
Decision
318d
Days
Class 2
Risk

K924242 is an FDA 510(k) clearance for the DISPOSABLE PERFORATOR. Classified as Drills, Burrs, Trephines & Accessories (compound, Powered) (product code HBF), Class II - Special Controls.

Submitted by Codman & Shurtleff, Inc. (Randolph, US). The FDA issued a Cleared decision on July 8, 1993 after a review of 318 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 K924242 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 1992
Decision Date July 08, 1993
Days to Decision 318 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
170d slower than avg
Panel avg: 148d · This submission: 318d
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 K924242.
CODMAN DISPOSABLE PERFORATOR, MODEL(S) 26-1222, 26-1223
K071931 · Codman & Shurtleff, Inc. · Oct 2007
ANSPACH ACCESS CRANIAL PERFORATOR
K982991 · The Anspach Effort, Inc. · Oct 1998
DISPOSABLE PERFORATOR
K933894 · Codman & Shurtleff, Inc. · Dec 1993
CODMAN * REUSABLE PERFORATOR
K820087 · Codman & Shurtleff, Inc. · Feb 1982
DISPOSABLE PERFORATORS, JACOBS, HUDSON
K791101 · Codman & Shurtleff, Inc. · Aug 1979