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FDA 510(k)

Uro-G HD Flexible Cystoscope

K-Number: K232837 · 2024-06-07

ApplicantUroviu Corporation
Decision Date2024-06-07
Product CodeFAJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Uro-G HD Flexible Cystoscope is the device name listed in this FDA 510(k) record. The listed applicant is Uroviu Corporation. It received FDA 510(k) clearance on 2024-06-07 under 510(k) number K232837. The device is classified under product code FAJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Uro-G HD Flexible Cystoscope?

Uro-G HD Flexible Cystoscope is a medical device that received FDA 510(k) clearance on 2024-06-07. The listed applicant is Uroviu Corporation. The 510(k) number is K232837.

When did Uro-G HD Flexible Cystoscope receive FDA 510(k) clearance?

Uro-G HD Flexible Cystoscope received FDA 510(k) clearance on 2024-06-07, under 510(k) number K232837.

Who is the listed applicant for Uro-G HD Flexible Cystoscope?

The FDA 510(k) record lists Uroviu Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Uro-G HD Flexible Cystoscope?

The FDA product code for Uro-G HD Flexible Cystoscope is FAJ.

Other records listing Uroviu Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253226UV5000W HandleK250797UV5000 HandleK243196Uro-G HD Cystoscope (1520)K202921Uro-G CystoscopeK182876Uro-N CystoscopeK171500Uro-V Cystoscope

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Related Devices (Code: FAJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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