Cleared Traditional

K001404 - GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES, GOLD TOTAL WITH FOUNTIAN HEAD, GOLD PISTON

K001404 is an FDA 510(k) clearance for GOLD TOTAL AND PARTIAL, manufactured by Mednet Locator, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code ETA cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K001404 · Mednet Locator, Inc. · Ear, Nose, Throat device
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Aug 2000
Decision
97d
Days
Class 2
Risk

K001404 is an FDA 510(k) clearance for the GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES,.... Classified as Replacement, Ossicular Prosthesis, Total (product code ETA), Class II - Special Controls.

Submitted by Mednet Locator, Inc. (Memphis, US). The FDA issued a Cleared decision on August 8, 2000 after a review of 97 days - within the typical 510(k) review window.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3495 - 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 Mednet Locator, Inc. devices

FDA 510(k) Submission Details - K001404

510(k) Number K001404 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 2000
Decision Date August 08, 2000
Days to Decision 97 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d slower than avg
Panel avg: 90d · This submission: 97d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ETA Device Classification - Class 2, Special Controls

Product Code ETA Replacement, Ossicular Prosthesis, Total
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3495
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 - ETA Replacement, Ossicular Prosthesis, Total

All 27
Devices cleared under the same product code (ETA) and FDA review panel - the closest regulatory comparables to K001404.
KURZ CLIP PISTON MVP, MODEL 1006 711-13/0.4 MM + 1006 761-63/0.6MM
K042503 · Heinz Kurz GmbH Medizintechnik · Oct 2004
TITANIUM OSSICULAR REPLACMENT SYSTEM
K030492 · Invotec International, Inc. · Mar 2003
MODULAR PORP AND TORP MODEL TBD
K002378 · Gyrus Ent LLC · Aug 2000
BOJRAB UNIVERSAL LONG IMLANT, MODEL TBD
K001902 · Gyrus Ent LLC · Jul 2000
ZURICH TITANIUM OSSICULAR REPLACEMENT SYSTEM
K993583 · Stryker Corp. · Nov 1999
MICROMEDICS S&T TOTAL OSSICULAR REPLACEMENT PROSTHESIS AND ACCESSORIES
K992138 · Micromedics, Inc. · Aug 1999