Fecha de decisión2022-11-09
Código de productoFAJ
Comité asesorGU
DecisiónSubstantially Equivalent
Resumen del dispositivo
Flexible Cystoscope (Model: CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US) is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai AnQing Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2022-11-09 under 510(k) number K222162. The device is classified under product code FAJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Preguntas frecuentes
What is the Flexible Cystoscope (Model: CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)?
Flexible Cystoscope (Model: CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US) is a medical device that received FDA 510(k) clearance on 2022-11-09. The listed applicant is Shanghai AnQing Medical Instrument Co., Ltd.. The 510(k) number is K222162.
When did Flexible Cystoscope (Model: CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US) receive FDA 510(k) clearance?
Flexible Cystoscope (Model: CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US) received FDA 510(k) clearance on 2022-11-09, under 510(k) number K222162.
Who is the listed applicant for Flexible Cystoscope (Model: CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)?
The FDA 510(k) record lists Shanghai AnQing Medical Instrument Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Flexible Cystoscope (Model: CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)?
The FDA product code for Flexible Cystoscope (Model: CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US) is FAJ.
Ensayos clínicos relacionados
Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.
Otros registros que enlistan a Shanghai AnQing Medical Instrument Co., Ltd. como solicitante
Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.
K254251InnovexView (GC146-17, GC150-20, GC155-23)K252806Flexible Suction Ureterorenoscope (US27G-12-EU, US27G-12-US, US33G-17-EU, US33G-17-US, US38G-20-EU, US38G-20-US.)K252598Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)K251752Flexible Bronchoscope (BS27U-12EU, BS27U-12US, BS38U-20EU, BS38U-20US)K243497Portable Video Processor (EA101), Flexible Bronchoscope BS41H-12EU, BS41H-12US, BS46H-17EU, BS50H-20EU, BS46H-17US, BS50H-20US, BS53H-22EU, BS53H-22US, BS55H-24EU, BS55H-24US, BS59H-28EU, BS59H-28USK243857Flexible Ureterorenoscope (US27F-12-EU; US27F-12-US) Ver todos los 14 dispositivos →
Dispositivos relacionados (Código: FAJ)
Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.
K260649OES ELITE Cystoscope and Accessories; Obturator, 17 Fr. (WA2C17BO); Obturator, 19.8 Fr. (WA2C19BO); Obturator, 21 Fr. (WA2C21BO); Obturator, 21 Fr., for sheath with ramp (WA2C21RO); Obturator, 21 Fr., long (WA2C21LO); Obturator, 21 Fr., for straight sheath (WA2C21SO); Obturator, 22.5 Fr. (WA2C22BO); Obturator, 25 Fr. (WA2C25BO); Obturator, optical, 19.8 Fr. (WA2C19BV); Obturator, optical, 21 Fr. (WA2C21BV); Obturator, optical, 21 Fr., for straight sheath (WA2C21SV); Obturator, optical,Olympus Winter & Ibe GmbHK253696CFlex Cystoscope - Standard Deflection (0570-0455); CFlex Cystoscope - Reverse Deflection (0570-0456); CystoView Monitor (0570-0465)Verathon Medical (Canada) UlcK253892Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope, 4 x 302 mm, view. Dir. 0°, standard, autoclavable); Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302AA HD-endoscope, 4 x 302 mm, view. Dir. 0°, wide angle, autoclavable); Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302BA HD-endoscope, 4 x 302 mm, view. Dir. 30°, wide angle, autoclavable); Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302BSA HD-endoscope, 4 x 302 mm, view. Dir. 30°,Strauss Surgical USAK253905PrimeSight UltraView SystemCogentix Medical, Inc.K260271Strauss Surgical cystoscope, hysteroscope and accessories InstrumentsAmerican Medical Endoscopy, Inc.K253226UV5000W HandleUroviu Corporation
Fuente oficial
Ver en la base de datos de la FDA →Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.