ESOFLIP ES— 510(k) K142000

Substantially Equivalent

Crospon, Ltd.

FDA 510(k) clearance K142000 for ESOFLIP ES, Substantially Equivalent on 2014-09-25. 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: 2014-07-23
Decision date: 2014-09-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bonita Springs, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code PIE

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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.