DeviceClearance

Quantum TTC Biliary Balloon Dilator— 510(k) K171223

Substantially Equivalent

Wilson-Cook Medical, Inc.

FDA 510(k) clearance K171223 for Quantum TTC Biliary Balloon Dilator, Substantially Equivalent on 2017-06-16. Applicant: Wilson-Cook Medical, Inc.. Device class: 2.

Clearance details

Applicant
Wilson-Cook Medical, 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
Winston-Salem, NC, US
Download summary PDFView on FDA.gov ↗

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More clearances from Wilson-Cook Medical, 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 K171223

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 K171223.

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