EsoFLIP® ES-310 Balloon Catheter— 510(k) K172128

Substantially Equivalent

Crospon, Ltd.

FDA 510(k) clearance K172128 for EsoFLIP® ES-310 Balloon Catheter, Substantially Equivalent on 2017-11-22. Applicant: Crospon, Ltd.. Device class: 2.

Clearance details

Applicant: Crospon, Ltd.
Product code: Code PIE
Device class: Class 2
Regulation: 21 CFR 876.5980
Advisory panel: Gastroenterology, Urology
Date received: 2017-07-14
Decision date: 2017-11-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Galway, IE

Download summary PDF View on FDA.gov ↗

Recent devices under product code PIE

K142000 — ESOFLIP ES2014-09-25

More clearances from Crospon, Ltd.

K183072 — EndoFLIP System2019-02-15
K170833 — EndoFLIP® System with FLIP Topography module2017-04-17
K160725 — EndoFLIP2016-05-01
K132337 — ESOFLIP BALLOON DILATION CATHETER2013-10-07
K130906 — ENDOFLIP CATHETER2013-07-17

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