EndoFLIP® System with FLIP Topography module— 510(k) K170833

Substantially Equivalent

Crospon, Ltd.

FDA 510(k) clearance K170833 for EndoFLIP® System with FLIP Topography module, Substantially Equivalent on 2017-04-17. Applicant: Crospon, Ltd..

Clearance details

Applicant: Crospon, Ltd.
Product code: Code FFX
Advisory panel: Gastroenterology, Urology
Date received: 2017-03-20
Decision date: 2017-04-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Galway, IE

Download summary PDF View on FDA.gov ↗

Adverse events under product code FFX

product code FFX

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.