Identifiers
- 510(k) Number
- K181760 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)
Transit-Pellets are a system for gastrointestinal motility, specifically designed for colonic transit testing. The device utilizes radiopaque markers to quantify the severity of transit problems and characterize colonic motility disorders.
This device is supplied as a standardized physiologic transit profiling system. It has received FDA 510(k) clearance under K181760 and is classified as a class 2 medical device.
Frequently asked questions
What is the primary purpose of the Transit-Pellets system?
Transit-Pellets are designed for colonic transit testing. The system uses radiopaque markers to help clinicians quantify the severity of transit problems and characterize specific colonic motility disorders.
How is the Transit-Pellets system regulated?
The device is classified as a class 2 medical device and has received FDA 510(k) clearance under K181760. This indicates that the device has been reviewed and found to be substantially equivalent to legally marketed predicate devices.
Which medical specialties utilize this system?
The Transit-Pellets system is categorized under the Gastroenterology and Urology advisory committees. It is specifically intended for use in clinical settings where gastrointestinal motility assessment is required.
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: Medifactia - Transit profiling, built on a validated method, Medifactia US, K222000 FDA 510 (k) - Transit-Pellets | Medifactia AB, Medifactia
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K181760 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medifactia AB
Sources (1)
- FDA 510(k) K181760 24 fields · synced Sep 24, 2026