Cleared Traditional

K943569 - STRYKER TOTAL PERFORMANCE SYSTEM

K943569 is the FDA 510(k) clearance for STRYKER TOTAL PERFORMANCE SYSTEM by Stryker Corp.. It is a Class 2 Ear, Nose, Throat device (product code ERL) cleared through the Traditional 510(k) pathway after a 171-day FDA review.

K943569 · Stryker Corp. · Ear, Nose, Throat device
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Jan 1995
Decision
171d
Days
Class 2
Risk

K943569 is an FDA 510(k) clearance for the STRYKER TOTAL PERFORMANCE SYSTEM. Classified as Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece (product code ERL), Class II - Special Controls.

Submitted by Stryker Corp. (Kalamazoo, US). The FDA issued a Cleared decision on January 9, 1995 after a review of 171 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4250 - the FDA ear, nose and throat 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 Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Stryker Corp. devices

Submission Details

510(k) Number K943569 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 1994
Decision Date January 09, 1995
Days to Decision 171 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
82d slower than avg
Panel avg: 89d · This submission: 171d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ERL Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.4250
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 Ear, Nose, Throat devices follow this clearance model.

Regulatory Peers - ERL Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece

All 54
Devices cleared under the same product code (ERL) and FDA review panel - the closest regulatory comparables to K943569.
STRYKER HUMMER II MICRODEBRIDER SYSTEM
K952681 · Stryker Endoscopy · Jul 1995
INTRAARC DRIVE SYSTEM
K951263 · Linvatec Corp. · Apr 1995
KARL STORZ INTRA-HANDPIECES AND ACCESSORIES
K950964 · KARL STORZ Endoscopy-America, Inc. · Mar 1995
APEX UNIVERSAL DRIVE SYSTEM
K944476 · Linvatec Corp. · Nov 1994
STRYKER MICRODEBRIDER SYSTEM
K940710 · Stryker Corp. · May 1994
TREACE MAGNUM OTO-TOOL SYSTEM
K873154 · Treace Medical, Inc. · Sep 1987