Cleared Traditional

K963899 - CAUSSE UNIVERSAL OSSICULAR REPLACEMENT ...

K963899 is an FDA 510(k) clearance for CAUSSE UNIVERSAL OSSICULAR REPLACEMENT ..., manufactured by Exmoor Plastics , Ltd.. The device is a Class 2 Ear, Nose, Throat device with product code ETA cleared through the Traditional 510(k) pathway after a 329-day FDA review.

K963899 · Exmoor Plastics , Ltd. · Ear, Nose, Throat device
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Aug 1997
Decision
329d
Days
Class 2
Risk

K963899 is an FDA 510(k) clearance for the CAUSSE UNIVERSAL OSSICULAR REPLACEMENT PROSTHESIS (ORP/1). Classified as Replacement, Ossicular Prosthesis, Total (product code ETA), Class II - Special Controls.

Submitted by Exmoor Plastics , Ltd. (Taunton, GB). The FDA issued a Cleared decision on August 22, 1997 after a review of 329 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Exmoor Plastics , Ltd. devices

FDA 510(k) Submission Details - K963899

510(k) Number K963899 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 1996
Decision Date August 22, 1997
Days to Decision 329 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
240d slower than avg
Panel avg: 89d · This submission: 329d
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 20
Devices cleared under the same product code (ETA) and FDA review panel - the closest regulatory comparables to K963899.
MICROMEDICS S&T TOTAL OSSICULAR REPLACEMENT PROSTHESIS AND ACCESSORIES
K992138 · Micromedics, Inc. · Aug 1999
BOJRAB MICRO-TORP, MODEL 7014-5845
K990601 · Gyrus Ent LLC · Mar 1999
MILLS COLUMELLA PROSTHESIS
K981088 · Exmoor Plastics , Ltd. · Jun 1998
RICHARDS TORP
K952549 · Smith & Nephew Richards, Inc. · Jul 1995
HAPEX MALLEABLE TORP
K950927 · Smith & Nephew Richards, Inc. · Mar 1995
BLACK OVAL-TOP TORP/PORP
K934107 · Smith & Nephew Richards, Inc. · Jun 1994