Cleared Traditional

K944476 - APEX UNIVERSAL DRIVE SYSTEM

K944476 is an FDA 510(k) clearance for APEX UNIVERSAL DRIVE SYSTEM, manufactured by Linvatec Corp.. The device is a Class 2 Ear, Nose, Throat device with product code ERL cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K944476 · Linvatec Corp. · Ear, Nose, Throat device
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Nov 1994
Decision
67d
Days
Class 2
Risk

K944476 is an FDA 510(k) clearance for the APEX UNIVERSAL DRIVE SYSTEM. Classified as Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece (product code ERL), Class II - Special Controls.

Submitted by Linvatec Corp. (Largo, US). The FDA issued a Cleared decision on November 18, 1994 after a review of 67 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K944476

510(k) Number K944476 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 1994
Decision Date November 18, 1994
Days to Decision 67 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 90d · This submission: 67d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ERL Device Classification - Class 2, Special Controls

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 89
Devices cleared under the same product code (ERL) and FDA review panel - the closest regulatory comparables to K944476.
BLACKSTAR(TM) STAR SYSTEM
K945659 · Xomed-Treace, Inc. · Jan 1995
ELECTRIC SURGICAL DRILL
K940016 · Alamo City Dental Supply Co. · Nov 1994
EDI-BUR MICRODRILL SYSTEMS
K945438 · Micromed Development Corp. · Nov 1994
MEDNEXT MICRO-DRILL
K943108 · Mednext, Inc. · Aug 1994
STRYKER MICRODEBRIDER SYSTEM
K940710 · Stryker Corp. · May 1994
DRILL MODULES MODELS 2116/2117
K914346 · Micro Surgical Instruments Corp. · Nov 1991
K944476 · APEX UNIVERSAL DRIVE SYSTEM
Download PDF Linvatec Corp.