T-Edge 10, T-Edge 11— 510(k) K213080

Clearance details

Applicant

Tuttnauer , Ltd.

Product code

Code FLE

Device class

Class 2

Regulation

21 CFR 880.6880

Advisory panel

General Hospital

Date received

2021-09-23

Decision date

2022-01-04

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Beit-Shemesh, IL

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Malfunction

444

Total

444

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 →