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FDA 510(k)

ProVee Video Processing Unit (PV-003)

K-Number: K251734 · 2025-09-24

ApplicantProverum Limited
Decision Date2025-09-24
Product CodeFET
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ProVee Video Processing Unit (PV-003) is the device name listed in this FDA 510(k) record. The listed applicant is Proverum Limited. It received FDA 510(k) clearance on 2025-09-24 under 510(k) number K251734. The device is classified under product code FET. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ProVee Video Processing Unit (PV-003)?

ProVee Video Processing Unit (PV-003) is a medical device that received FDA 510(k) clearance on 2025-09-24. The listed applicant is Proverum Limited. The 510(k) number is K251734.

When did ProVee Video Processing Unit (PV-003) receive FDA 510(k) clearance?

ProVee Video Processing Unit (PV-003) received FDA 510(k) clearance on 2025-09-24, under 510(k) number K251734.

Who is the listed applicant for ProVee Video Processing Unit (PV-003)?

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

What is the FDA product code for ProVee Video Processing Unit (PV-003)?

The FDA product code for ProVee Video Processing Unit (PV-003) is FET.

Other records listing Proverum Limited 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.

PMA P250011STENT, URETHRAL, PROSTATIC, PERMANENT OR SEMI-PERMANENT

Related Devices (Code: FET)

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.

K261880FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01Fujifilm CorporationK261260HD Camera Head OLYMPUS CH-S200-08-LBOlympus Medical Systems CorporationK250462UL UHD-Clear View 4K Camera System (UL-3Chip 4K)Univlabs Technologies Private LimitedK250204Endoscopic Camera SystemShenzhen Sophway Technology Co., Ltd.K243260FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860RFujifilm CorporationK242067VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700; VISERA ELITE III LED LIGHT SOURCE OLYMPUS CLL-S700; 4K CAMERA HEAD OLYMPUS CH-S700-XZ-EAOlympus Corporations of the Americas

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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