Flexible Bronchoscope (BS27U-12EU, BS27U-12US, BS38U-20EU, BS38U-20US)

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K251752

by Shanghai Anqing Medical Instrument Co., Ltd

Identifiers

510(k) Number: K251752 FDA 510(k)
FDA Product Code: EOQ FDA 510(k)
Models / Variants: BS27U-12EU FDA 510(k)EUDAMED
BS27U-12US FDA 510(k)EUDAMED
BS38U-20EU FDA 510(k)EUDAMED
BS38U-20US FDA 510(k)EUDAMED

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 874.4680 FDA 510(k)
Regulation Number: 874.4680 FDA 510(k)
Advisory Committee: Ear, Nose, Throat FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

The Flexible Bronchoscope (BS27U-12EU, BS27U-12US, BS38U-20EU, BS38U-20US) is a diagnostic and therapeutic device classified as a flexible bronchoscope, designed for visualisation and intervention within the airways and tracheobronchial tree. It enables direct inspection, biopsy, and procedural access to the bronchial passages, aiding in the diagnosis and treatment of respiratory conditions.

This device is supplied as a reusable medical instrument, intended for use in clinical settings such as otolaryngology and pulmonary medicine. It is authorised under FDA 510K and MDR regulations, with a traditional clearance process through the Ear, Nose, and Throat advisory committee. The models differ by working length (12mm or 20mm) and regional specifications (EU or US), ensuring compatibility with local standards and equipment.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Flexible Bronchoscope (BS27U-12EU, BS27U-12US, BS38U-20EU, BS38U-20US ..., Flexible Bronchoscope (BS27U-12EU, BS27U-12US… - FDA.report, Flexible Bronchoscope (BS27U-12EU, BS27U-12US, BS38U-20EU, BS38U-20US)

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class II	Active
FDA 510(k)	United States	FDA_510K	K251752	Class II	Active

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Manufacturer

Manufacturer: Shanghai Anqing Medical Instrument Co., Ltd
FDA Applicant: Shanghai AnQing Medical Instrument Co., Ltd.

Sources (2)

FDA 510(k) K251752 24 fields · synced Oct 6, 2026
EUDAMED 1 fields · synced May 18, 2026