Cleared Traditional

K000256 - CAP PORP

K000256 is the FDA 510(k) clearance for CAP PORP 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 14-day FDA review.

K000256 · Gyrus Ent LLC · Ear, Nose, Throat device
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Feb 2000
Decision
14d
Days
Class 2
Risk

K000256 is an FDA 510(k) clearance for the CAP PORP, CAP TORP. 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 February 11, 2000 after a review of 14 days - a notably fast clearance 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: 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 K000256 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 2000
Decision Date February 11, 2000
Days to Decision 14 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
75d faster than avg
Panel avg: 89d · This submission: 14d
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 K000256.
TITANIUM MIDDLE EAR PROSTHESES
K002897 · Xomed, Inc. · Oct 2000
SMITH & NEPHEW OFF-CENTERED PORP
K002464 · Gyrus Ent LLC · Aug 2000
WEHRS INCUS-STAPES
K000858 · Gyrus Ent LLC · Apr 2000
MICROMEDICS S&T PARTIAL OSSICULAR REPLACEMENT PROSTHESIS
K993234 · Micromedics, Inc. · Nov 1999
EXMOOR TEFLON LOOP REPLACEMENT PROSTHESIS
K981045 · Exmoor Plastics , Ltd. · May 1998
MILLS INCUS HA SLEEVE
K974365 · Exmoor Plastics , Ltd. · Jan 1998