Cleared Traditional

ALM Tube I.D. 6.0, O.D. 8.2 (520843), ALM Tube I.D. 7.0, O.D. 9.7 (520845), ALM Tube I.D. 7.5, O.D. 10.3 (520846), ALM Tube I.D. 8.0, O.D. 11.0 (520847)

K242852 · Inomed Medizintechnik GmbH · Ear, Nose, Throat
Jun 2025
Decision
266d
Days
Class 2
Risk

About This 510(k) Submission

K242852 is an FDA 510(k) clearance for the ALM Tube I.D. 6.0, O.D. 8.2 (520843), ALM Tube I.D. 7.0, O.D. 9.7 (520845), ALM Tube I.D. 7.5, O.D. 10.3 (520846), ALM Tube I.D. 8.0, O.D. 11.0 (520847), a Stimulator, Nerve (Class II — Special Controls, product code ETN), submitted by Inomed Medizintechnik GmbH (Emmendingen, DE). The FDA issued a Cleared decision on June 13, 2025, 266 days after receiving the submission on September 20, 2024. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.1820.

Submission Details

510(k) Number K242852 FDA.gov
FDA Decision Cleared SESE
Date Received September 20, 2024
Decision Date June 13, 2025
Days to Decision 266 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF

Device Classification

Product Code ETN — Stimulator, Nerve
Device Class Class II — Special Controls
CFR Regulation 21 CFR 874.1820

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