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

Name: FDA 510(k) clearance K170833
Creator: U.S. Food and Drug Administration
Published: 2017-04-17

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.. Device class: 2.

Clearance details

Applicant: Crospon, Ltd.
Product code: Code FFX
Device class: Class 2
Regulation: 21 CFR 876.1725
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 ↗

Recent devices under product code FFX

view all

K252605 — mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001)2025-12-05
K240007 — Solar Compact (G4-1)2024-05-06
K231861 — EndoflipTM 300 System2023-07-21
K223705 — EndoflipTM 3002023-04-14
K222000 — Transit-Pellets2023-01-18

More clearances from Crospon, Ltd.

view all

K183072 — EndoFLIP System2019-02-15
K172128 — EsoFLIP® ES-310 Balloon Catheter2017-11-22
K160725 — EndoFLIP2016-05-01
K142000 — ESOFLIP ES2014-09-25
K132337 — ESOFLIP BALLOON DILATION CATHETER2013-10-07

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.