Flexible Bronchoscope (BS27U-12EU, BS27U-12US, BS38U-20EU, BS38U-20US)— 510(k) K251752

Substantially Equivalent

Shanghai AnQing Medical Instrument Co., Ltd.

FDA 510(k) clearance K251752 for Flexible Bronchoscope (BS27U-12EU, BS27U-12US, BS38U-20EU, BS38U-20US), Substantially Equivalent on 2025-08-27. Applicant: Shanghai AnQing Medical Instrument Co., Ltd.. Device class: 2.

Clearance details

Applicant
Shanghai AnQing Medical Instrument Co., Ltd.
Product code
Code EOQ
Device class
Class 2
Regulation
21 CFR 874.4680
Advisory panel
Ear, Nose, Throat
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Shanghai, CN
Download summary PDFView on FDA.gov ↗

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Adverse events under product code EOQ

product code EOQ
Death
135
Injury
2,863
Malfunction
21,662
Total
24,660

Source: openFDA MAUDE database, through . 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.