Video Bronchoscope System +2 more models

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K241612

by Hunan Vathin Medical Instrument Co., Ltd.

Identifiers

510(k) Number: K241612 FDA 510(k)
FDA Product Code: EOQ FDA 510(k)
Models / Variants: Video Bronchoscope System FDA 510(k)EUDAMED
Single-use Flexible Bronchoscope (BC-S1E00-L, BC-S1H00-L, BC-S1J00-L, BC-S1E00, BC-S1H00, BC-S1J00.) FDA 510(k)EUDAMED
Digital Video Monitor (DVM-D1, DVM-D2) 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 Video Bronchoscope System is a single-use flexible bronchoscope designed for endoscopic visualization of the airways, including the trachea, bronchi, and lungs. It integrates a digital imaging system to provide real-time video output, facilitating diagnostic and therapeutic procedures in respiratory medicine.

This system is supplied as a sterile, single-use device and includes compatible digital video monitors (DVM-D1, DVM-D2). The bronchoscope models (BC-S1E00-L, BC-S1H00-L, BC-S1J00-L, BC-S1E00, BC-S1H00, BC-S1J00) are intended for use in clinical settings, with regulatory authorisations including FDA 510K clearance under the Ear, Nose, and Throat advisory committee. Storage and handling must comply with manufacturer guidelines to maintain sterility and functionality.

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.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

European Union Active

MDD

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class II	Active
EUDAMED	European Union	MDD	—	Class II	Active
FDA 510(k)	United States	FDA_510K	K241612	Class II	Active

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Manufacturer

Manufacturer: Hunan Vathin Medical Instrument Co., Ltd.

Sources (2)

FDA 510(k) K241612 24 fields · synced Sep 18, 2026
EUDAMED 1 fields · synced May 19, 2026