K220399

Substantially Equivalent

WiScope Digital Bronchoscope System, WiScope Single-Use Digital Flexible Bronchoscope, WiScope Image System

Applicant: OTU Medical, Inc.
Product code: EOQ
Advisory panel: Ear, Nose, Throat
Date received: 2022-02-11
Decision date: 2022-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Jose, CA, US

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.