EndoFLIP— 510(k) K160725

Name: FDA 510(k) clearance K160725
Creator: U.S. Food and Drug Administration
Published: 2016-05-01

Substantially Equivalent

Crospon, Ltd.

FDA 510(k) clearance K160725 for EndoFLIP, Substantially Equivalent on 2016-05-01. 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: 2016-03-16
Decision date: 2016-05-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Galway, IE

Download summary PDF View on FDA.gov ↗

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More clearances from Crospon, Ltd.

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K183072 — EndoFLIP System2019-02-15
K172128 — EsoFLIP® ES-310 Balloon Catheter2017-11-22
K170833 — EndoFLIP® System with FLIP Topography module2017-04-17
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.