Cleared Special

K013573 - CLIP PARTIAL PROSTHESIS-TITANIUM DRESDEN, MODEL 1002 250-257 (FDA 510(k) Clearance)

Class II Ear, Nose, Throat device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K013573 · Heinz Kurz GmbH Medizintechnik · Ear, Nose, Throat device
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Nov 2001
Decision
11d
Days
Class 2
Risk

K013573 is an FDA 510(k) clearance for the CLIP PARTIAL PROSTHESIS-TITANIUM DRESDEN, MODEL 1002 250-257. 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 November 9, 2001 after a review of 11 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

Submission Details

510(k) Number K013573 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 2001
Decision Date November 09, 2001
Days to Decision 11 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
78d faster than avg
Panel avg: 89d · This submission: 11d
Pathway characteristics
Modification to existing cleared device.

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 73
Devices cleared under the same product code (ETB) and FDA review panel - the closest regulatory comparables to K013573.
mGRIP Partial Prosthesis (0.75 mm) (58669)
K260718 · Med-El Elektromedizinische Ger?te GmbH · Apr 2026
mWING Stapes Prosthesis (0.4 x 3.50 mm) (58717)
K260720 · Med-El Elektromedizinische Ger?te GmbH · Apr 2026
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