Identifiers
- 510(k) Number
- K101191 FDA 510(k)
- FDA Product Code
- FDF 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 Naviaid ICVI Device is a disposable accessory for flexible endoscopes, classified as a Colonoscope and Accessories, Flexible/Rigid. It assists in advancing the endoscope through the small intestine by deploying a distal balloon within the instrument channel, which acts as an anchor when inflated. This aids in precise navigation and improved visualization during procedures in gastroenterology and urology.
The device is supplied as a single-use accessory, including a distal balloon, inflation tube, and an Air Supply Unit (ASU). It is intended for use in controlled clinical settings, such as endoscopy suites, and requires sterile handling. The device carries an FDA 510(k) clearance (K101191) and is regulated under the classification FDF (Flexible Diagnostic Endoscope). No MRI safety information is specified, and storage conditions are not detailed in the provided data.
Frequently asked questions
What specialties does the Naviaid ICVI Device support during endoscopic procedures?
The Naviaid ICVI Device is designed to assist in procedures within the specialties of gastroenterology and urology. Its primary function is to aid in advancing flexible endoscopes through the small intestine, improving navigation and visualization during these specialized examinations.
Is the Naviaid ICVI Device reusable or intended for single-use, and how should it be handled?
The Naviaid ICVI Device is explicitly labeled as a single-use accessory, meaning it is not meant to be reused after one procedure. Due to its sterile nature, it must be handled in a controlled clinical setting, such as an endoscopy suite, with strict adherence to sterile protocols to ensure patient safety.
What key components are included in the Naviaid ICVI Device package, and how does it work?
The device includes a distal balloon, an inflation tube, and an Air Supply Unit (ASU). It works by deploying the distal balloon within the endoscope’s instrument channel, which, when inflated, acts as an anchor to stabilize the scope and facilitate smoother advancement through the small intestine, enhancing procedural precision.
Does the Naviaid ICVI Device have any specific regulatory approvals or pathways, and how is it classified?
The Naviaid ICVI Device holds an FDA 510(k) clearance (K101191), confirming it is deemed substantially equivalent to a legally marketed predicate device. It is classified under the Flexible Diagnostic Endoscope (FDF) category and is intended for use in controlled clinical settings like endoscopy suites.
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: NAVIAID ICVI DEVICE (K101191) — FDA 510 (k) | Innolitics, Naviaid Icvi-f Device, Naviaid Icvi-s Device, Naviaid Icvi-b Device ..., PDF k-IIo-cil - accessdata.fda.gov, NaviAid™ AB - Smart Medical Systems
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K101191 | Class II | Active |
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Manufacturer
- Manufacturer
- Smart Medical Systems Ltd
- FDA Applicant
- Smart Medical Systems , Ltd.
Sources (1)
- FDA 510(k) K101191 24 fields · synced Sep 19, 2026