Cleared Traditional

K002378 - MODULAR PORP AND TORP MODEL TBD

K002378 is the FDA 510(k) clearance for MODULAR PORP AND TORP MODEL TBD by Gyrus Ent LLC. It is a Class 2 Ear, Nose, Throat device (product code ETA) cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K002378 · Gyrus Ent LLC · Ear, Nose, Throat device
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Aug 2000
Decision
25d
Days
Class 2
Risk

K002378 is an FDA 510(k) clearance for the MODULAR PORP AND TORP MODEL TBD. Classified as Replacement, Ossicular Prosthesis, Total (product code ETA), 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 25 days - a notably fast clearance cycle.

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: 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 K002378 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 2000
Decision Date August 29, 2000
Days to Decision 25 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
64d faster than avg
Panel avg: 89d · This submission: 25d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 K002378.
mGRIP Total Prosthesis (3.00 mm) (58689)
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mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO Total Prosthesis Kit
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FISCH TITANIUM MIDDLE EAR PROSTHESES
K043375 · Karl Storz Endoscopy · Jan 2005
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