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

Clearance details

Applicant

Inomed Medizintechnik GmbH

Product code

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

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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 →