DeviceClearance

Gyrus ACMI EZDilate 3-Stage Balloon Dilatation Catheter— 510(k) K180086

Substantially Equivalent

Gyrus Acmi, Inc.

FDA 510(k) clearance K180086 for Gyrus ACMI EZDilate 3-Stage Balloon Dilatation Catheter, Substantially Equivalent on 2018-03-08. Applicant: Gyrus Acmi, Inc.. Device class: 2.

Clearance details

Applicant
Gyrus Acmi, Inc.
Product code
Code FGE
Device class
Class 2
Regulation
21 CFR 876.5010
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Southborough, MA, US
Download summary PDFView on FDA.gov ↗

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More clearances from Gyrus Acmi, Inc.

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Adverse events under product code FGE

product code FGE
Death
52
Injury
2,347
Malfunction
9,798
Other
1
Total
12,198

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K180086

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K180086.

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