ProVee Video Processing Unit PV-003
510(k) K251734
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK251734 | Date24 Sep 2025 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- FET
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.1500
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
The ProVee Video Processing Unit PV-003 is an Endoscopic Video Imaging System/Component, designed to receive, process, and display live imaging signals from endoscopic visualization devices. It serves as a critical accessory for endoscopic procedures, enhancing visualization for diagnostic and therapeutic applications in gastroenterology and urology.
This reusable, non-patient-contacting device is integrated into the ProVee System for BPH (Benign Prostatic Hyperplasia) and operates as part of a Class 2 medical device under FDA 510(k) clearance (K251734). Supplied as a standalone unit, it adheres to regulatory standards for endoscopic imaging systems, with no specified sterility requirements beyond standard reusable medical device protocols. The device is not intended for MRI use and must be stored in accordance with manufacturer guidelines to maintain functionality.
Other devices from Proverum, Ltd.
Questions
AI-generated answers, 20 Sep 2026
What specialties is the ProVee Video Processing Unit (PV-003) primarily intended for in clinical practice?
The ProVee Video Processing Unit (PV-003) is designed for use in gastroenterology and urology procedures. It enhances visualization during endoscopic imaging, making it particularly useful for diagnostic and therapeutic applications in these specialties, such as BPH (Benign Prostatic Hyperplasia) interventions.
Is the ProVee Video Processing Unit (PV-003) a single-use or reusable device, and what maintenance is required?
The ProVee Video Processing Unit (PV-003) is a reusable, non-patient-contacting device. Since it is not intended for direct patient contact, it does not require sterilization but must be cleaned and maintained according to the manufacturer’s guidelines to ensure proper functionality and longevity.
How is the ProVee Video Processing Unit (PV-003) regulated, and what does its FDA clearance status mean for buyers?
The ProVee Video Processing Unit (PV-003) holds FDA 510(k) clearance (K251734), meaning it has been determined to be substantially equivalent to a legally marketed device in its category. This clearance confirms that it meets regulatory standards for endoscopic video imaging systems and is suitable for use in the U.S. market as part of the ProVee System for BPH.
Can the ProVee Video Processing Unit (PV-003) be used with MRI equipment, and what storage guidelines should be followed?
The ProVee Video Processing Unit (PV-003) is not intended for MRI use, so it should not be placed in an MRI environment. For proper functionality, it must be stored according to the manufacturer’s guidelines, which likely include protection from environmental damage, dust, and moisture to maintain performance.
What types of endoscopic procedures is the ProVee Video Processing Unit (PV-003) compatible with, and how is it supplied?
The ProVee Video Processing Unit (PV-003) is designed to work with endoscopic visualization devices used in gastroenterology and urology, particularly within the ProVee System for BPH. It is supplied as a standalone unit, meaning it can be integrated into existing endoscopic setups without requiring additional patient-contacting components.