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FDA 510(k)

UV5000 Handle

K-Number: K250797 · 2025-09-11

ApplicantUroviu Corporation
Decision Date2025-09-11
Product CodeFAJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

UV5000 Handle is the device name listed in this FDA 510(k) record. The listed applicant is Uroviu Corporation. It received FDA 510(k) clearance on 2025-09-11 under 510(k) number K250797. 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 UV5000 Handle?

UV5000 Handle is a medical device that received FDA 510(k) clearance on 2025-09-11. The listed applicant is Uroviu Corporation. The 510(k) number is K250797.

When did UV5000 Handle receive FDA 510(k) clearance?

UV5000 Handle received FDA 510(k) clearance on 2025-09-11, under 510(k) number K250797.

Who is the listed applicant for UV5000 Handle?

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 UV5000 Handle?

The FDA product code for UV5000 Handle 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 HandleK243196Uro-G HD Cystoscope (1520)K232837Uro-G HD Flexible CystoscopeK202921Uro-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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