Cleared Traditional

K964548 - APEX UNIVERSAL DRIVE SYSTEM

K964548 is the FDA 510(k) clearance for APEX UNIVERSAL DRIVE SYSTEM by Linvatec Corp.. It is a Class 2 Ear, Nose, Throat device (product code ERL) cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K964548 · Linvatec Corp. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1997
Decision
65d
Days
Class 2
Risk

K964548 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 January 17, 1997 after a review of 65 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.

View all Linvatec Corp. devices

Submission Details

510(k) Number K964548 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1996
Decision Date January 17, 1997
Days to Decision 65 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
24d faster than avg
Panel avg: 89d · This submission: 65d
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 K964548.
INTEGRATED DRIVE/PUMP SYSTEM FOR OTOLARYNGOLOGY
K981637 · Linvatec Corp. · Jul 1998
STRYKER HUMMER II MICRODEBRIDER SYSTEM
K972584 · Stryker Endoscopy · Oct 1997
XPS STRAIGHTSHOT MICRORESECTOR
K972453 · Xomed, Inc. · Sep 1997
ANSPACH MICROMAX SYSTEM
K965080 · The Anspach Effort, Inc. · Jan 1997
IRRIGATION SYSTEM
K961192 · Linvatec Corp. · Apr 1996
STRYKER HUMMER II MICRODEBRIDER SYSTEM
K952681 · Stryker Endoscopy · Jul 1995