VIDEO BRONCHOSCOPE SYSTEM— 510(k) K141366

Substantially Equivalent

Scholly Fiberoptic GmbH

FDA 510(k) clearance K141366 for VIDEO BRONCHOSCOPE SYSTEM, Substantially Equivalent on 2014-12-17. Applicant: Scholly Fiberoptic GmbH.

Clearance details

Applicant: Scholly Fiberoptic GmbH
Product code: Code EOQ
Advisory panel: Ear, Nose, Throat
Date received: 2014-05-23
Decision date: 2014-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Denzlingen, DE

Download summary PDF View on FDA.gov ↗

Adverse events under product code EOQ

product code EOQ

Death: 135
Injury: 2,863
Malfunction: 21,662
Total: 24,660

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.