Cleared Traditional

K973356 - K-PISTON WITH BAND HOOK /ANGULAR PISTON

K973356 is an FDA 510(k) clearance for K-PISTON WITH BAND HOOK /ANGULAR PISTON, manufactured by Heinz Kurz. The device is a Class 2 Ear, Nose, Throat device with product code ETB cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K973356 · Heinz Kurz · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1997
Decision
74d
Days
Class 2
Risk

K973356 is an FDA 510(k) clearance for the K-PISTON WITH BAND HOOK /ANGULAR PISTON. Classified as Prosthesis, Partial Ossicular Replacement (product code ETB), Class II - Special Controls.

Submitted by Heinz Kurz (Dusslingen, DE). The FDA issued a Cleared decision on November 21, 1997 after a review of 74 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 Heinz Kurz devices

FDA 510(k) Submission Details - K973356

510(k) Number K973356 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 1997
Decision Date November 21, 1997
Days to Decision 74 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
16d faster than avg
Panel avg: 90d · This submission: 74d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 54
Devices cleared under the same product code (ETB) and FDA review panel - the closest regulatory comparables to K973356.
TUBINGEN TITANIUM PROSTHESIS (TTP) VARIO, MODELS AERIAL 1004 010 & BELL 1002 010
K990923 · Heinz Kurz · Mar 1999
EXMOOR TEFLON LOOP REPLACEMENT PROSTHESIS
K981045 · Exmoor Plastics , Ltd. · May 1998
MILLS INCUS HA SLEEVE
K974365 · Exmoor Plastics , Ltd. · Jan 1998
PARTIAL/TOTAL/POROUS POLYETHYLENE OSSICULAR REPLACEMENT
K972815 · Grace Medical, Inc. · Oct 1997
PARTIAL OSSICULAR REPLACEMENT PROSTHESIS (PORP)
K972734 · Mednet Locator, Inc. · Sep 1997
CAUSSE PISTON
K972737 · Mednet Locator, Inc. · Sep 1997