Cleared Traditional

K911901 - MAXI CABINET OPTIONAL BUILT IN S6000 LI...

K911901 is an FDA 510(k) clearance for MAXI CABINET OPTIONAL BUILT IN S6000 LI..., manufactured by Stortz. The device is a Class 1 Ear, Nose, Throat device with product code ETF cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K911901 · Stortz · Ear, Nose, Throat device
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Jul 1991
Decision
88d
Days
Class 1
Risk

K911901 is an FDA 510(k) clearance for the MAXI CABINET OPTIONAL BUILT IN S6000 LIGHT SOURCE. Classified as Unit, Examining/treatment, Ent (product code ETF), Class I - General Controls.

Submitted by Stortz (Saint Louis, US). The FDA issued a Cleared decision on July 26, 1991 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.5300 - 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 Stortz devices

FDA 510(k) Submission Details - K911901

510(k) Number K911901 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 1991
Decision Date July 26, 1991
Days to Decision 88 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1d faster than avg
Panel avg: 89d · This submission: 88d
Pathway characteristics
Predicate-based equivalence.

ETF Device Classification - Class 1, General Controls

Product Code ETF Unit, Examining/treatment, Ent
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.5300
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - ETF Unit, Examining/treatment, Ent

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