K242416

Substantially Equivalent

Single-use Flexible Bronchoscope: BC-E1C10, BC-E1C11, BC-E1C12, BC-E1E10, BC-E1E11, BC-E1E12, BC-E1H10, BC-E1H11, BC-E1H12; Digital Video Monitor: DVM-D1, DVM-D2; Single-use sampler: S-20mL, S-30mL, S-50mL

Applicant: Hunan Vathin Medical Instrument Co., Ltd.
Product code: EOQ
Advisory panel: Ear, Nose, Throat
Date received: 2024-08-15
Decision date: 2025-01-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Xiangtan, CN

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.