ESOFLIP BALLOON DILATION CATHETER— 510(k) K132337

Name: FDA 510(k) clearance K132337
Creator: U.S. Food and Drug Administration
Published: 2013-10-07

Substantially Equivalent

Crospon, Ltd.

FDA 510(k) clearance K132337 for ESOFLIP BALLOON DILATION CATHETER, Substantially Equivalent on 2013-10-07. Applicant: Crospon, Ltd.. Device class: 2.

Clearance details

Applicant: Crospon, Ltd.
Product code: Code PID
Device class: Class 2
Regulation: 21 CFR 876.5980
Advisory panel: Gastroenterology, Urology
Date received: 2013-07-26
Decision date: 2013-10-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bonita Springs, FL, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K132337

K-number listed on FDA's recall record

Z-2038-2024 — EsoFLIP, 30mm BALLOON DILATION CATHETER, REF ES-330, Rx OnlyClass II·Ongoing·Covidien, LLC·20240425

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K132337.

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