Cleared Special

K021479 - CLIP PISTON AWENGEN

K021479 is an FDA 510(k) clearance for CLIP PISTON AWENGEN, manufactured by Heinz Kurz GmbH Medizintechnik. The device is a Class 2 Ear, Nose, Throat device with product code ETB cleared through the Special 510(k) pathway after a 13-day FDA review.

K021479 · Heinz Kurz GmbH Medizintechnik · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2002
Decision
13d
Days
Class 2
Risk

K021479 is an FDA 510(k) clearance for the CLIP PISTON AWENGEN, MODEL# 1006 805 - 1006 861. Classified as Prosthesis, Partial Ossicular Replacement (product code ETB), Class II - Special Controls.

Submitted by Heinz Kurz GmbH Medizintechnik (Amsterdam, Nh, NL). The FDA issued a Cleared decision on May 21, 2002 after a review of 13 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Heinz Kurz GmbH Medizintechnik devices

FDA 510(k) Submission Details - K021479

510(k) Number K021479 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 2002
Decision Date May 21, 2002
Days to Decision 13 days
Submission Type Special
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 89d · This submission: 13d
Pathway characteristics
Modification to existing cleared device.

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 37
Devices cleared under the same product code (ETB) and FDA review panel - the closest regulatory comparables to K021479.
mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes Prosthesis
K241142 · Med-El Elektromedizinische Ger?te GmbH · Jan 2025
mCLIP Partial Prosthesis, mCLIP ARC Partial Prosthesis, mXACT Partial Prosthesis and mXACT PRO Partial Prosthesis Kit
K241261 · Med-El Elektromedizinische Ger?te GmbH · Jan 2025
SMART OFFSET STAPES PISTON
K033554 · Gyrus Ent LLC · Nov 2003
SMITH & NEPHEW PISTONS
K003214 · Gyrus Ent LLC · Oct 2000
SMITH & NEPHEW PORPS & TORPS
K002737 · Gyrus Ent LLC · Oct 2000
TITANIUM MIDDLE EAR PROSTHESES
K002897 · Xomed, Inc. · Oct 2000