Colibri Endoscopy System— 510(k) K192305

Substantially Equivalent

3nt Medical , Ltd.

FDA 510(k) clearance K192305 for Colibri Endoscopy System, Substantially Equivalent on 2020-02-27. Applicant: 3nt Medical , Ltd..

Clearance details

Applicant: 3nt Medical , Ltd.
Product code: Code EOB
Advisory panel: Ear, Nose, Throat
Date received: 2019-08-23
Decision date: 2020-02-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Rosh Ha'Ayin, IL

Download summary PDF View on FDA.gov ↗

Adverse events under product code EOB

product code EOB

Malfunction: 6,143
Total: 6,143

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.