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)— 510(k) K242852

Name: FDA 510(k) clearance K242852
Creator: U.S. Food and Drug Administration
Published: 2025-06-13

Substantially Equivalent

Inomed Medizintechnik GmbH

FDA 510(k) clearance K242852 for 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), Substantially Equivalent on 2025-06-13. Applicant: Inomed Medizintechnik GmbH. Device class: 2.

Clearance details

Applicant: Inomed Medizintechnik GmbH
Product code: Product code ETN
Device class: Class 2
Regulation: 21 CFR 874.1820
Advisory panel: Ear, Nose, Throat
Date received: 2024-09-20
Decision date: 2025-06-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Emmendingen, DE

Download summary PDF View on FDA.gov ↗

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K233001 — Bioscope Neuromonitor Device2024-12-13
K241917 — EARP Nerve Cuff Electrode2024-07-31
K232888 — Disposable Laryngeal Electrodes2023-12-21

More clearances from Inomed Medizintechnik GmbH

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Adverse events under product code ETN

product code ETN

Death: 7
Injury: 327
Malfunction: 2,776
Total: 3,110

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.