Cleared Traditional

K962564 - RICHARDS TOTAL/PARTIAL PROSTHESIS

K962564 is an FDA 510(k) clearance for RICHARDS TOTAL/PARTIAL PROSTHESIS, manufactured by Gyrus Ent LLC. The device is a Class 2 Ear, Nose, Throat device with product code ETB cleared through the Traditional 510(k) pathway after a 205-day FDA review.

K962564 · Gyrus Ent LLC · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1997
Decision
205d
Days
Class 2
Risk

K962564 is an FDA 510(k) clearance for the RICHARDS TOTAL/PARTIAL PROSTHESIS. 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 January 22, 1997 after a review of 205 days - an extended review 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: 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

FDA 510(k) Submission Details - K962564

510(k) Number K962564 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1996
Decision Date January 22, 1997
Days to Decision 205 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
115d slower than avg
Panel avg: 90d · This submission: 205d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ETB Device Classification - Class 2, Special Controls

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 54
Devices cleared under the same product code (ETB) and FDA review panel - the closest regulatory comparables to K962564.
CAUSSE PISTON
K972737 · Mednet Locator, Inc. · Sep 1997
BELL PROSTHESIS (PARTIAL)
K972492 · Heinz Kurz · Aug 1997
ESTERM MALLEUS TOTAL AND PARTIAL MIDDLE EAR PROSTHESIS
K964909 · Xomed, Inc. · Mar 1997
PARTIAL OSSICULAR REPLACEMENT PROSTHESIS
K964798 · Anthony D. Prescott · Jan 1997
PARTIAL & TOTAL OSSICULAR REPLACEMENT PROSTHESIS
K963752 · Grace Medical, Inc. · Oct 1996
POLY/PLATINUM WIRE PISTON
K945105 · Micromed Development Corp. · May 1996