FDA 510(k)

Single-use Extraction Baskets

N.º K: K240192 · 2024-10-15

SolicitanteScivita Medical Technology Co., Ltd.

Fecha de decisión2024-10-15

Código de productoLQR

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Single-use Extraction Baskets is the device name listed in this FDA 510(k) record. The listed applicant is Scivita Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-10-15 under 510(k) number K240192. The device is classified under product code LQR. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Single-use Extraction Baskets?

Single-use Extraction Baskets is a medical device that received FDA 510(k) clearance on 2024-10-15. The listed applicant is Scivita Medical Technology Co., Ltd.. The 510(k) number is K240192.

When did Single-use Extraction Baskets receive FDA 510(k) clearance?

Single-use Extraction Baskets received FDA 510(k) clearance on 2024-10-15, under 510(k) number K240192.

Who is the listed applicant for Single-use Extraction Baskets?

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

What is the FDA product code for Single-use Extraction Baskets?

The FDA product code for Single-use Extraction Baskets is LQR.

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Otros registros que enlistan a Scivita Medical Technology Co., Ltd. como solicitante

K262552Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B)K251338Cholangioscope Visualization System (Single-use Video Cholangioscope: SCV-P-01G, SCV-P-02G; Full HD Visualization Endoscopic Image Processor: HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D)K243708Urology Videoscope System (Single-use Flexible Ureteroscope: SUV-1A-B, SUV-1A-P, SUV-2A-B, SUV-2A-P, SUV-2B-B, SUB-2B-P, SUV-2C-B, SUV-2C-P;Single-use Flexible Cystoscope: SUV-1D-B, SUV-1D-P; Endoscopic Image Processor: HDVS-S100A, HDVS-S100D.)K250210Broncho Videoscope System (Single-use Broncho Videoscope (SBV-1A-B, SBV-1A-P, SBV-1B-B, SBV-1B-P, SBV-1C-B, SBV-1C-P); Full HD Visualization Endoscopic Image Processor (HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D); Endoscopic Image Processor (HDVS-S100A, HDVS-S100D))K240289Full HD Endoscopic Image Processor (HDVS-S200A, HDVS-S200B, HDVS-S200C, HDVS-S200D)K231521Broncho Videoscope System

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Dispositivos relacionados (Código: LQR)

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Fuente oficial

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