Identifiers
- 510(k) Number
- K160725 FDA 510(k)
- FDA Product Code
- FFX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.1725 FDA 510(k)
- Regulation Number
- 876.1725 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The EndoFLIP System is a Gastrointestinal Motility (Electrical) System designed to measure the functional lumen diameter (FLD) of the gastric stoma in patients with a gastric band. It employs an endoscopically placed, balloon-based catheter to assess the patency and size of the stoma, aiding in the evaluation of gastric band efficacy and patient management.
The device is supplied as a single-use, sterile system and is intended for use in clinical settings such as endoscopy suites. It includes a balloon catheter (e.g., EF-325n, EF-325l) and associated instrumentation for measurement. The EndoFLIP System is classified as a Class II medical device under FDA regulations (21 CFR 876.1725) and has received FDA 510(k) clearance for use in gastroenterology and urology procedures. No MRI safety information is specified.
Frequently asked questions
What is the primary clinical purpose of the EndoFLIP System, and how does it differ from traditional gastric band evaluations?
The EndoFLIP System measures the functional lumen diameter (FLD) of the gastric stoma in patients with a gastric band, helping assess stoma patency and the effectiveness of the band. Unlike traditional methods that rely on subjective symptoms or imaging, it uses an endoscopically placed balloon catheter to provide objective, real-time measurements of stoma size, aiding in tailored patient management decisions.
Is the EndoFLIP System reusable, or is it intended for single-use only? How should it be handled post-procedure?
The EndoFLIP System is explicitly designed for single-use only and is supplied sterile. After use, it should be disposed of according to standard clinical waste protocols for single-use medical devices, as reuse is not supported by the manufacturer.
What balloon catheter models are included in the EndoFLIP System, and how do they differ?
The system includes balloon catheters labeled EF-325n and EF-325l, though the specific differences between these models (e.g., length, technical variations) are not detailed in the provided data. Both are part of the same system and are intended for endoscopically guided placement within the gastric stoma.
Where should the EndoFLIP System be stored, and are there any specific environmental requirements?
The EndoFLIP System is intended for use in clinical settings like endoscopy suites, where controlled conditions are maintained. While exact storage requirements (e.g., temperature, humidity) aren’t specified, standard sterile medical device storage practices—such as keeping it in a sealed, protected environment until use—should be followed to preserve sterility and functionality.
How was the EndoFLIP System’s equivalence to prior devices determined, and which advisory committee reviewed its submission?
The system was deemed substantially equivalent (SE) to prior devices through a Traditional 510(k) review process, meaning the FDA determined it had the same intended use and technological characteristics as legally marketed alternatives. The submission was reviewed by the Gastroenterology and Urology (GU) Advisory Committee, reflecting its dual clinical relevance in those specialties.
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: ENDOFLIP by CROSPON, LTD. | FDA 510 (k) Summary, Medtronic - Crospon Endoflip Manuals and Documents | Medical, K183072 - EndoFLIP System - Gastroenterology & Urology, Crospon, Ltd. - 12 FDA 510 (k) Gastroenterology & Urology Devices ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K160725 | Class II | Active |
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Manufacturer
- Manufacturer
- Crospon, Ltd.
Sources (1)
- FDA 510(k) K160725 24 fields · synced Sep 18, 2026