Cleared Traditional

K071150 - TROCAR VENTILATION TUBE/WITH TROCAR TIP

K071150 is an FDA 510(k) clearance for TROCAR VENTILATION TUBE/WITH TROCAR TIP, manufactured by Heinz Kurz GmbH Medizintechnik. The device is a Class 2 Ear, Nose, Throat device with product code ETD cleared through the Traditional 510(k) pathway after a 231-day FDA review.

K071150 · Heinz Kurz GmbH Medizintechnik · Ear, Nose, Throat device
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Optimized for regulatory review, auditing and printing
Dec 2007
Decision
231d
Days
Class 2
Risk

K071150 is an FDA 510(k) clearance for the TROCAR VENTILATION TUBE/WITH TROCAR TIP, TROCAR HANDLE, MODEL 1015 074, 1015 .... Classified as Tube, Tympanostomy (product code ETD), Class II - Special Controls.

Submitted by Heinz Kurz GmbH Medizintechnik (Amsterdam, NL). The FDA issued a Cleared decision on December 12, 2007 after a review of 231 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3880 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Heinz Kurz GmbH Medizintechnik devices

FDA 510(k) Submission Details - K071150

510(k) Number K071150 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 2007
Decision Date December 12, 2007
Days to Decision 231 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
142d slower than avg
Panel avg: 89d · This submission: 231d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ETD Device Classification - Class 2, Special Controls

Product Code ETD Tube, Tympanostomy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3880
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 - ETD Tube, Tympanostomy

All 69
Devices cleared under the same product code (ETD) and FDA review panel - the closest regulatory comparables to K071150.
Ventilation (Tympanostomy) Tubes
K151067 · Medtronic Xomed, Inc. · Jul 2015
ACCLARENT TYMPANOSTOMY TUBE AND TYMPANOSTOMY TUBE DELIVERY SYSTEM
K103595 · Acclarent, Inc. · Apr 2011
TYMPANOSTOMY TUBE
K082188 · Acclarent, Inc. · Sep 2008
PC COATED FLUOROPLASTIC VENT TUBES
K000801 · Gyrus Ent LLC · Jun 2000
SILVERSTEIN MICROWICK
K991670 · Micromedics, Inc. · Aug 1999
FLUOROPLASTIC VENTILATION TUBES
K992222 · Gyrus Ent LLC · Aug 1999