Cleared Traditional

K962564 - RICHARDS TOTAL/PARTIAL PROSTHESIS

K962564 is the FDA 510(k) clearance for RICHARDS TOTAL/PARTIAL PROSTHESIS 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 205-day FDA review.

K962564 · Gyrus Ent LLC · Ear, Nose, Throat device
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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

Submission Details

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
116d slower than avg
Panel avg: 89d · This submission: 205d
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 K962564.
EXMOOR TEFLON LOOP REPLACEMENT PROSTHESIS
K981045 · Exmoor Plastics , Ltd. · May 1998
MILLS INCUS HA SLEEVE
K974365 · Exmoor Plastics , Ltd. · Jan 1998
ESTERM MALLEUS TOTAL AND PARTIAL MIDDLE EAR PROSTHESIS
K964909 · Xomed, Inc. · Mar 1997
RICHARDS PORP
K952481 · Smith & Nephew Richards, Inc. · Jun 1995
HAPEX MALLEABLE PORP
K950885 · Smith & Nephew Richards, Inc. · Mar 1995
HAPEX PORP
K950886 · Smith & Nephew Richards, Inc. · Mar 1995