RIGIFLEX SINGLE-USE ACHALASIA BALLOON DILATOR— 510(k) K050232

Name: FDA 510(k) clearance K050232
Creator: U.S. Food and Drug Administration
Published: 2005-03-11

Substantially Equivalent

Boston Scientific Corp

FDA 510(k) clearance K050232 for RIGIFLEX SINGLE-USE ACHALASIA BALLOON DILATOR, Substantially Equivalent on 2005-03-11. Applicant: Boston Scientific Corp. Device class: 2.

Clearance details

Applicant: Boston Scientific Corp
Product code: Code PID
Device class: Class 2
Regulation: 21 CFR 876.5980
Advisory panel: Gastroenterology, Urology
Date received: 2005-02-01
Decision date: 2005-03-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Natick,, MA, US

Download summary PDF View on FDA.gov ↗

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K132337 — ESOFLIP BALLOON DILATION CATHETER2013-10-07

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Recalls naming K050232

K-number listed on FDA's recall record

Z-1671-2013 — RigiflexTM 11 Single-Use Achalasia Balloon Dilator, Material Number (UPN) M00554510 Product Usage: The Boston Scientific Corporation RigiflexTM II Single- Use Achalasia Balloon Dilator is indicated for dilatation of the cardia in patients with achalasia.Class III·Terminated·Boston Scientific Corporation·20130528

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K050232.

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