← Back to catalogue

Endo Flip

FDA 510(k)

Class II (US FDA 510(k))

510(k) K102214

by Crospon, Ltd.

Identifiers

510(k) Number
K102214 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 assess the functional competence of the gastroesophageal junction. It employs impedance planimetry to measure pressure and cross-sectional area during swallowing, providing objective data on lower esophageal sphincter function and motility disorders.

This device is intended for use in clinical settings, including gastroenterology and urology, and is supplied as a reusable medical instrument. It is not sterile and requires proper cleaning and maintenance between uses. The system operates under FDA 510(k) clearance (K102214) and adheres to regulatory standards outlined in 21 CFR 876.1725. No MRI safety information is specified.

Frequently asked questions

What clinical specialties primarily use the EndoFLIP System, and why is it relevant to them?

The EndoFLIP System is primarily used in gastroenterology and urology clinics. It assesses the functional competence of the gastroesophageal junction using impedance planimetry, providing objective data on lower esophageal sphincter (LES) function and motility disorders. This helps diagnose conditions like gastroesophageal reflux disease (GERD), achalasia, and other motility impairments, which are key concerns in both specialties.

Is the EndoFLIP System reusable, and what cleaning or maintenance is required between uses?

Yes, the EndoFLIP System is designed as a reusable medical instrument. Since it is not sterile, it requires proper cleaning and maintenance between uses to ensure accuracy and hygiene. Manufacturers typically provide guidelines for disinfection and storage to prevent contamination and preserve functionality.

How many different models or configurations of the EndoFLIP System are available, and what distinguishes them?

The EndoFLIP System includes multiple registration numbers and FEI numbers, indicating several distinct models or configurations (e.g., 3010381606, 3012480535, etc.). While exact differences aren’t specified, these identifiers suggest variations in sensor design, catheter length, or impedance planimetry capabilities. Clinicians should confirm compatibility with their specific diagnostic needs.

What regulatory pathway was followed for FDA clearance of the EndoFLIP System, and what does that mean for users?

The EndoFLIP System received FDA 510(k) clearance (K102214) under a Traditional review with a Substantially Equivalent (SESE) determination. This means the device was deemed comparable to a legally marketed predicate device, ensuring it meets safety and effectiveness standards. Users can rely on this clearance as evidence of regulatory validation for clinical use in gastroenterology and urology.

Can the EndoFLIP System be used in environments where MRI scans are performed, and why?

There is no MRI safety information specified for the EndoFLIP System. This means its compatibility with MRI environments is not confirmed or documented, and it should not be assumed safe for use in or near MRI machines. Clinicians should avoid exposing the device to MRI fields unless explicit manufacturer guidance permits it.

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: Endo Flip 510 (k) FDA Premarket Notification K102214 CROSPON, LTD., Irish Firm Crospon Unveils Endoflip Gastroenterology., PDF K170833 - EndoFLIP® System with FLIP Topography module, Crospon, Ltd. - 12 FDA 510 (k) Gastroenterology & Urology Devices ..., Endoflip™ 300 impedance planimetry system - Medtronic

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Crospon, Ltd.

Sources (1)

  • FDA 510(k) K102214 24 fields · synced Sep 19, 2026