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..

Clearance details

Applicant: Crospon, Ltd.
Product code: Code PIE
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 ↗

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