EzVu Visual Vasopressor Injector (EV-19)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K241595 FDA 510(k)
- FDA Product Code
- FBK FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.1500 FDA 510(k)
- Regulation Number
- 876.1500 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The EzVu Visual Vasopressor Injector (EV-19) is an Endoscopic Injection Needle designed for precise vasopressor delivery during endoscopic procedures. Its transparent distal window enables real-time visualization of vascular puncture, enhancing safety by detecting inadvertent blood vessel injury early and with greater sensitivity than conventional opaque needles.
This single-use, non-sterile device is intended for use in gastroenterology and urology procedures. The EV-19 features a 33-cm length and 5-mm diameter hollow shaft with a clear terminal window for improved visibility. It is regulated under 21 CFR 876.1500 and holds an FDA 510(k) clearance (K241595). Storage and handling should follow standard sterile instrument protocols prior to use.
Frequently asked questions
What procedures is the EzVu Visual Vasopressor Injector designed to assist with, and how does its transparency improve safety during these procedures?
The EzVu Visual Vasopressor Injector (EV-19) is designed for use in gastroenterology and urology procedures, specifically for precise vasopressor delivery during endoscopic interventions. Its transparent distal window allows real-time visualization of the vascular puncture site, enabling clinicians to detect inadvertent blood vessel injury earlier and with greater sensitivity than traditional opaque needles. This feature enhances safety by reducing the risk of complications from unintended vascular damage.
Is the EzVu Visual Vasopressor Injector single-use or reusable, and what sterility considerations should be followed?
The EzVu Visual Vasopressor Injector is a single-use device and is non-sterile as supplied. To ensure sterility before use, it must be processed following standard sterile instrument protocols (e.g., sterilization via autoclave, ethylene oxide, or other validated methods) prior to clinical application. This aligns with best practices for endoscopic instruments to prevent infection.
What are the dimensions of the EzVu Visual Vasopressor Injector, and how might these affect its use in different endoscopic procedures?
The EV-19 features a 33-centimeter length and a 5-millimeter diameter hollow shaft, designed for compatibility with standard endoscopic channels. These dimensions allow for precise maneuverability during procedures while accommodating the delivery of vasopressors. The length ensures adequate reach for deep tissue access, while the diameter balances flexibility with structural integrity for safe injection.
How is the regulatory pathway for the EzVu Visual Vasopressor Injector structured, and what does this mean for clinicians or facilities considering adoption?
The EzVu Visual Vasopressor Injector holds an FDA 510(k) clearance (K241595) under 21 CFR 876.1500, indicating it is classified as substantially equivalent to a predicate device. This means it has undergone FDA review for safety and effectiveness, and its use is authorized for the specified endoscopic applications in gastroenterology and urology. Clinicians or facilities adopting this device can rely on its regulatory clearance as evidence of compliance with U.S. standards.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: EzVu Visual Vasopressor, Vasopressin - Veol Medical Technologies - VMT, EzVu Visual Vasopressor injector (EV-19) (K241595) — FDA 510 (k ..., K241595 FDA 510(k) - EzVu Visual Vasopressor injector (EV-19)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K241595 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Veol Medical Technologies Pvt. Ltd.
- FDA Applicant
- Veol Medical Technologies Pvt , Ltd.
Sources (1)
- FDA 510(k) K241595 24 fields · synced Sep 19, 2026