Cleared Traditional

K000801 - PC COATED FLUOROPLASTIC VENT TUBES

K000801 is the FDA 510(k) clearance for PC COATED FLUOROPLASTIC VENT TUBES by Gyrus Ent LLC. It is a Class 2 Ear, Nose, Throat device (product code ETD) cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K000801 · Gyrus Ent LLC · Ear, Nose, Throat device
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Jun 2000
Decision
98d
Days
Class 2
Risk

K000801 is an FDA 510(k) clearance for the PC COATED FLUOROPLASTIC VENT TUBES. Classified as Tube, Tympanostomy (product code ETD), Class II - Special Controls.

Submitted by Gyrus Ent LLC (Bartlett, US). The FDA issued a Cleared decision on June 19, 2000 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3880 - 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 Gyrus Ent LLC devices

Submission Details

510(k) Number K000801 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 2000
Decision Date June 19, 2000
Days to Decision 98 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
9d slower than avg
Panel avg: 89d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ETD Tube, Tympanostomy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3880
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 - ETD Tube, Tympanostomy

All 68
Devices cleared under the same product code (ETD) and FDA review panel - the closest regulatory comparables to K000801.
Ventilation (Tympanostomy) Tubes
K151067 · Medtronic Xomed, Inc. · Jul 2015
ACCLARENT TYMPANOSTOMY TUBE AND TYMPANOSTOMY TUBE DELIVERY SYSTEM
K103595 · Acclarent, Inc. · Apr 2011
TYMPANOSTOMY TUBE
K082188 · Acclarent, Inc. · Sep 2008
SILVERSTEIN MICROWICK
K991670 · Micromedics, Inc. · Aug 1999
FLUOROPLASTIC VENTILATION TUBES
K992222 · Gyrus Ent LLC · Aug 1999
EXMOOR MYRINGOTOMY KIT
K980828 · Exmoor Plastics , Ltd. · Oct 1998