FDA 510(k)

VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box

Numéro K : K223926 · 2023-10-06

DemandeurMedimaging Integrated Solution, Inc (Miis)

Date de décision2023-10-06

Code produitFAJ

Comité consultatifGU

DécisionSubstantially Equivalent

Résumé du dispositif

VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box is the device name listed in this FDA 510(k) record. The listed applicant is Medimaging Integrated Solution, Inc (Miis). It received FDA 510(k) clearance on 2023-10-06 under 510(k) number K223926. 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 VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box?

VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box is a medical device that received FDA 510(k) clearance on 2023-10-06. The listed applicant is Medimaging Integrated Solution, Inc (Miis). The 510(k) number is K223926.

When did VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box receive FDA 510(k) clearance?

VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box received FDA 510(k) clearance on 2023-10-06, under 510(k) number K223926.

Who is the listed applicant for VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box?

The FDA 510(k) record lists Medimaging Integrated Solution, Inc (Miis) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box?

The FDA product code for VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box is FAJ.

Essais cliniques associés

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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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