Cleared Traditional

K003994 - KSEA UNIDRIVE II/II PLUS AND ENT ACCESS...

K003994 is the FDA 510(k) clearance for KSEA UNIDRIVE II/II PLUS AND ENT ACCESS... by KARL STORZ Endoscopy-America, Inc.. It is a Class 2 Ear, Nose, Throat device (product code ERL) cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K003994 · KARL STORZ Endoscopy-America, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2001
Decision
108d
Days
Class 2
Risk

K003994 is an FDA 510(k) clearance for the KSEA UNIDRIVE II/II PLUS AND ENT ACCESSORIES. Classified as Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece (product code ERL), Class II - Special Controls.

Submitted by KARL STORZ Endoscopy-America, Inc. (Culver City, US). The FDA issued a Cleared decision on April 13, 2001 after a review of 108 days - within the typical 510(k) review window.

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 KARL STORZ Endoscopy-America, Inc. devices

Submission Details

510(k) Number K003994 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 2000
Decision Date April 13, 2001
Days to Decision 108 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
19d slower than avg
Panel avg: 89d · This submission: 108d
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 K003994.
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K040300 · Stryker Instruments · Mar 2004
MODIFICATION TO XPS 3000 SYSTEM
K011321 · Medtronic Xomed, Inc. · Jun 2001
HUMMER IV MICRODEBRIDER SYSTEM
K011381 · Stryker Instruments · May 2001
XPS NITRO SYSTEM
K002828 · Xomed, Inc. · Oct 2000
HUMMER TRAK SYSTEM
K990038 · Stryker Endoscopy · Feb 1999
PNEUMATIC CUTTER SYSTEM
K983050 · Surgical Laser Technologies, Inc. · Nov 1998