Cleared Traditional

K780956 - OTOLOGICAL VENTILATION TUBES

K780956 is the FDA 510(k) clearance for OTOLOGICAL VENTILATION TUBES by Mcghan Medical Corp.. It is a Class 2 Ear, Nose, Throat device (product code ETD) cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K780956 · Mcghan Medical Corp. · Ear, Nose, Throat device
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Jun 1978
Decision
13d
Days
Class 2
Risk

K780956 is an FDA 510(k) clearance for the OTOLOGICAL VENTILATION TUBES. Classified as Tube, Tympanostomy (product code ETD), Class II - Special Controls.

Submitted by Mcghan Medical Corp. (Mchenry, US). The FDA issued a Cleared decision on June 22, 1978 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 874.3880 - 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 Mcghan Medical Corp. devices

Submission Details

510(k) Number K780956 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 1978
Decision Date June 22, 1978
Days to Decision 13 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
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
Predicate-based equivalence. No clinical trials required.

Device Classification

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 64
Devices cleared under the same product code (ETD) and FDA review panel - the closest regulatory comparables to K780956.
VENTILATION TUBE. SILI. DONALDSON TYPE
K781258 · Xomed, Inc. · Aug 1978
VENTILATION TUBE TEFLON SHEPARD TYPE
K781259 · Xomed, Inc. · Aug 1978
VENTILATION TUBE SILICONE PAPARELLA TYPE
K781260 · Xomed, Inc. · Aug 1978
PULLEN PLASTIC-PORE PLUGS
K772066 · Richard'S Medical Equip., Inc. · Dec 1977
PLASTI-PORE BOBBIN DRAIN TUBE, OTOLOGY
K760439 · Richard'S Medical Equip., Inc. · Sep 1976
SPOON-BOBBIN DRAIN TUBE W/ WIRE, OTOLOGY
K760438 · Richard'S Medical Equip., Inc. · Sep 1976