EvoEndo Single-Use Endoscopy System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K250900 FDA 510(k)
- FDA Product Code
- FDS 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 EvoEndo Single-Use Endoscopy System is a flexible gastroscope and accessories designed for single-use diagnostic and therapeutic procedures in gastroenterology and urology. It combines an ultra-slim, flexible scope with four-way steering for enhanced maneuverability, enabling visualization and intervention in the upper gastrointestinal and urinary tracts.
This system is supplied as a single-use, sterile device intended for use in clinical settings such as outpatient clinics, endoscopy suites, and procedural rooms. The scope is compatible with MRI environments and comes in a pre-packaged, ready-to-use configuration. Authorized under FDA 510(k) clearance (K250900), it adheres to regulatory standards for Class II medical devices (regulation number 876.1500) and is distributed with specific FEI and registration numbers for traceability.
Frequently asked questions
Is the EvoEndo Single-Use Endoscopy System reusable or designed for single-use only, and what does this mean for infection control in my clinic?
The EvoEndo Single-Use Endoscopy System is explicitly designed for single-use only, meaning each scope is intended for one procedure and must be discarded afterward. This eliminates the need for reprocessing, reducing infection control risks like cross-contamination or instrument damage from repeated sterilization. The pre-packaged, sterile configuration further ensures safety, as it’s ready-to-use out of the box without requiring manual cleaning or sterilization between patients.
Can this scope be used in MRI environments, and if so, does that limit its compatibility with other imaging modalities?
Yes, the EvoEndo Single-Use Endoscopy System is MRI-compatible, allowing safe use in MRI environments without interference. However, compatibility with other imaging modalities (e.g., CT or fluoroscopy) isn’t specified in the data, so clinicians should verify integration with their specific imaging systems before use. The slim, flexible design prioritizes maneuverability in tight anatomical spaces, which may also influence compatibility with certain accessories or guides.
What sizes or models are available for the EvoEndo Single-Use Endoscopy System, and how do I determine which one fits my patient’s needs?
The data doesn’t specify exact sizes or model variations (e.g., length, diameter, or channel dimensions) for the EvoEndo system. However, it is described as an ultra-slim, flexible gastroscope with four-way steering, which suggests it’s designed for access to narrow or complex anatomical pathways in both gastroenterology (upper GI) and urology (urinary tract). To select the appropriate model, consult the manufacturer’s product catalog or technical specifications, as these details are critical for procedures like ERCP, cystoscopy, or biopsy in tight spaces.
How should the EvoEndo Single-Use Endoscopy System be stored, and are there any special handling requirements before use?
The system is supplied in a pre-packaged, ready-to-use configuration, implying it should be stored in its original, sealed packaging to maintain sterility until immediately before use. Storage conditions aren’t detailed, but standard practices for single-use endoscopy devices—such as keeping it in a clean, dry environment away from direct sunlight or extreme temperatures—should apply. Always check the packaging for expiration dates or integrity before opening, as compromised seals could compromise sterility.
What traceability features are included with the EvoEndo Single-Use Endoscopy System, and how do they help with inventory and compliance?
The system includes FEI (Final Establishment Identifier) numbers and registration numbers for each unit, which enable precise traceability in regulatory registries like FDA’s OpenFDA. These identifiers help track devices for recall purposes, inventory management, and compliance with reporting requirements (e.g., FDA’s Unique Device Identifier system). Clinics can use these numbers to log usage, verify authenticity, and ensure adherence to single-use protocols without reprocessing.
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: EvoEndo® Single-Use Unsedated Endoscopy System, EvoEndo® Sedation-Free Endoscopy System, EvoEndo® Single-Use Unsedated Endoscopy System
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K250900 | Class II | Active |
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Manufacturer
- Manufacturer
- Evoendo, Inc.
Sources (1)
- FDA 510(k) K250900 24 fields · synced Sep 19, 2026