FDA 510(k)

Single-use Flexible Bronchoscope

N.º K: K261637 · 2026-09-23

SolicitanteHunan Vathin Medical Instrument Co., Ltd.

Fecha de decisión2026-09-23

Código de productoEOQ

Comité asesorEN

DecisiónSubstantially Equivalent

Resumen del dispositivo

Single-use Flexible Bronchoscope is the device name listed in this FDA 510(k) record. The listed applicant is Hunan Vathin Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2026-09-23 under 510(k) number K261637. The device is classified under product code EOQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Single-use Flexible Bronchoscope?

Single-use Flexible Bronchoscope is a medical device that received FDA 510(k) clearance on 2026-09-23. The listed applicant is Hunan Vathin Medical Instrument Co., Ltd.. The 510(k) number is K261637.

When did Single-use Flexible Bronchoscope receive FDA 510(k) clearance?

Single-use Flexible Bronchoscope received FDA 510(k) clearance on 2026-09-23, under 510(k) number K261637.

Who is the listed applicant for Single-use Flexible Bronchoscope?

The FDA 510(k) record lists Hunan Vathin Medical Instrument Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Single-use Flexible Bronchoscope?

The FDA product code for Single-use Flexible Bronchoscope is EOQ.

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Otros registros que enlistan a Hunan Vathin Medical Instrument Co., Ltd. como solicitante

K250232Vathin® Video Bronchoscope System K251599Single-use Ureteral Access Sheath K250785Single-use Flexible Ureteroscope K243117Digital Video Processor K242416Single-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 K242535Single-use Flexible Cystoscope (CY-E2E01, CY-E2E01R, CY-E2F01, CY-E2F01R, CY-E2G01, CY-E2G01R, CY-S2E01, CY-S2E01R); Digital Video Monitor (DVM-D1, DVM-D2)

Ver todos los 18 dispositivos →

Dispositivos relacionados (Código: EOQ)

K260309Ambu® aScope™ 5 Broncho 2.7/1.2; Ambu® aScope™ 5 Broncho 4.2/2.2; Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler SetAmbu A/S K2540263.8mm Slim ProVu Video Bronchoscope (090-02-0038U); 5.0mm Regular ProVu Video Bronchoscope (090-02-0050U); 6.0mm Large ProVu Video Bronchoscope (090-02-0060U); ProVu Video Bronchoscope 8 display (040-07-0082U)Flexicare Medical Limited.K260382MONARCH™ Platform (MON-000008)Auris Health, Inc.K254037LungFlow Airway CatheterFree Flow Medical, Inc.K253137FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840TFujifilm Corporation K260565SmartClip Delivery Catheter (ADR-1715)Elucent Medical

Fuente oficial

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