Cleared Traditional

K932470 - LANGGASSE 90

K932470 is an FDA 510(k) clearance for LANGGASSE 90, manufactured by Happersberger Otopront GmbH. The device is a Class 1 Ear, Nose, Throat device with product code ETF cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K932470 · Happersberger Otopront GmbH · Ear, Nose, Throat device
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Aug 1993
Decision
97d
Days
Class 1
Risk

K932470 is an FDA 510(k) clearance for the LANGGASSE 90. Classified as Unit, Examining/treatment, Ent (product code ETF), Class I - General Controls.

Submitted by Happersberger Otopront GmbH (Germany, GR). The FDA issued a Cleared decision on August 25, 1993 after a review of 97 days - within the typical 510(k) review window.

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: 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 Happersberger Otopront GmbH devices

FDA 510(k) Submission Details - K932470

510(k) Number K932470 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 1993
Decision Date August 25, 1993
Days to Decision 97 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
8d slower than avg
Panel avg: 89d · This submission: 97d
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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