Cleared Traditional

K971943 - MYRINGOTOMY TUBE

K971943 is an FDA 510(k) clearance for MYRINGOTOMY TUBE, manufactured by Mednet Locator, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code ETD cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K971943 · Mednet Locator, Inc. · Ear, Nose, Throat device
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Jul 1997
Decision
57d
Days
Class 2
Risk

K971943 is an FDA 510(k) clearance for the MYRINGOTOMY TUBE. Classified as Tube, Tympanostomy (product code ETD), Class II - Special Controls.

Submitted by Mednet Locator, Inc. (Memphis, US). The FDA issued a Cleared decision on July 23, 1997 after a review of 57 days - a notably fast clearance 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: 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 Mednet Locator, Inc. devices

FDA 510(k) Submission Details - K971943

510(k) Number K971943 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 1997
Decision Date July 23, 1997
Days to Decision 57 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 90d · This submission: 57d
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 89
Devices cleared under the same product code (ETD) and FDA review panel - the closest regulatory comparables to K971943.
SHAH PERMAVENT
K974007 · Exmoor Plastics , Ltd. · Dec 1997
TUBINGEN TYMPANIC VENTILATION TUBE, TYMPANIC VENTILATION TUBES WITH ENE/S, DIABOLO TYMPANIC VENTILATION TUBE, MINIMAL T)
K973226 · Heinz Kurz GmbH Medizintechnik · Nov 1997
MYRINGOTOMY TUBE
K972126 · Mednet Locator, Inc. · Jul 1997
MYRINGOTOMY TUBE - BOBBIN WITH TAB
K972400 · Mednet Locator, Inc. · Jul 1997
TYMPANOSTOMY VENTILATION TUBE
K971454 · Ikonos Corp. · May 1997
TM MICRO-CATHETERS
K971124 · Xomed, Inc. · May 1997