FDA 510(k)

Cystoscope System

Numéro K : K231118 · 2023-11-13

DemandeurShenzhen HugeMed Medical Technical Development Co., Ltd.

Date de décision2023-11-13

Code produitFAJ

Comité consultatifGU

DécisionSubstantially Equivalent

Résumé du dispositif

Cystoscope System is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen HugeMed Medical Technical Development Co., Ltd.. It received FDA 510(k) clearance on 2023-11-13 under 510(k) number K231118. The device is classified under product code FAJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Cystoscope System?

Cystoscope System is a medical device that received FDA 510(k) clearance on 2023-11-13. The listed applicant is Shenzhen HugeMed Medical Technical Development Co., Ltd.. The 510(k) number is K231118.

When did Cystoscope System receive FDA 510(k) clearance?

Cystoscope System received FDA 510(k) clearance on 2023-11-13, under 510(k) number K231118.

Who is the listed applicant for Cystoscope System?

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

What is the FDA product code for Cystoscope System?

The FDA product code for Cystoscope System is FAJ.

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Dispositifs connexes (Code : FAJ)

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 GmbH K253696CFlex Cystoscope - Standard Deflection (0570-0455); CFlex Cystoscope - Reverse Deflection (0570-0456); CystoView Monitor (0570-0465)Verathon Medical (Canada) Ulc K253892Strauss 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 USA K253905PrimeSight UltraView SystemCogentix Medical, Inc.K260271Strauss Surgical cystoscope, hysteroscope and accessories InstrumentsAmerican Medical Endoscopy, Inc.K253226UV5000W HandleUroviu Corporation

Source officielle

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