Cleared Traditional

K943541 - 75K STAIGHT DRILL

K943541 is the FDA 510(k) clearance for 75K STAIGHT DRILL by Stryker Corp.. It is a Class 2 Neurology device (product code HBE) cleared through the Traditional 510(k) pathway after a 300-day FDA review.

K943541 · Stryker Corp. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1995
Decision
300d
Days
Class 2
Risk

K943541 is an FDA 510(k) clearance for the 75K STAIGHT DRILL. Classified as Drills, Burrs, Trephines & Accessories (simple, Powered) (product code HBE), Class II - Special Controls.

Submitted by Stryker Corp. (Portage, US). The FDA issued a Cleared decision on May 18, 1995 after a review of 300 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4310 - 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 Stryker Corp. devices

Submission Details

510(k) Number K943541 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 1994
Decision Date May 18, 1995
Days to Decision 300 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
152d slower than avg
Panel avg: 148d · This submission: 300d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HBE Drills, Burrs, Trephines & Accessories (simple, Powered)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4310
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 - HBE Drills, Burrs, Trephines & Accessories (simple, Powered)

All 40
Devices cleared under the same product code (HBE) and FDA review panel - the closest regulatory comparables to K943541.
STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM
K032303 · Stryker Instruments · Jan 2004
CRANIOCUT
K022942 · Aesculap, Inc. · Oct 2002
ANSPACH ANGLED MICRONOSE ATTACHMENT
K002903 · The Anspach Effort, Inc. · Oct 2000
MICRO-AIRE WIRE PASS AND CRANIOTOME DRILL
K903664 · Micro-Aire Surgical Instruments, Inc. · Sep 1990