Cleared Traditional

K002464 - SMITH & NEPHEW OFF-CENTERED PORP

K002464 is the FDA 510(k) clearance for SMITH & NEPHEW OFF-CENTERED PORP by Gyrus Ent LLC. It is a Class 2 Ear, Nose, Throat device (product code ETB) cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K002464 · Gyrus Ent LLC · Ear, Nose, Throat device
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Aug 2000
Decision
19d
Days
Class 2
Risk

K002464 is an FDA 510(k) clearance for the SMITH & NEPHEW OFF-CENTERED PORP. Classified as Prosthesis, Partial Ossicular Replacement (product code ETB), Class II - Special Controls.

Submitted by Gyrus Ent LLC (Bartlett, US). The FDA issued a Cleared decision on August 29, 2000 after a review of 19 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3450 - 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 Gyrus Ent LLC devices

Submission Details

510(k) Number K002464 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 2000
Decision Date August 29, 2000
Days to Decision 19 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
70d faster than avg
Panel avg: 89d · This submission: 19d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ETB Prosthesis, Partial Ossicular Replacement
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3450
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 - ETB Prosthesis, Partial Ossicular Replacement

All 36
Devices cleared under the same product code (ETB) and FDA review panel - the closest regulatory comparables to K002464.
SMITH & NEPHEW PISTONS
K003214 · Gyrus Ent LLC · Oct 2000
SMITH & NEPHEW PORPS & TORPS
K002737 · Gyrus Ent LLC · Oct 2000
TITANIUM MIDDLE EAR PROSTHESES
K002897 · Xomed, Inc. · Oct 2000
WEHRS INCUS-STAPES
K000858 · Gyrus Ent LLC · Apr 2000
CAP PORP, CAP TORP
K000256 · Gyrus Ent LLC · Feb 2000
MICROMEDICS S&T PARTIAL OSSICULAR REPLACEMENT PROSTHESIS
K993234 · Micromedics, Inc. · Nov 1999