GORE VIABIL Short Wire Biliary Endoprosthesis— 510(k) K170740
UnknownW. L. Gore & Associates, Inc.
FDA 510(k) clearance K170740 for GORE VIABIL Short Wire Biliary Endoprosthesis, Unknown on 2017-05-08. Applicant: W. L. Gore & Associates, Inc.. Device class: 2.
Clearance details
- Applicant
- W. L. Gore & Associates, Inc.
- Product code
- Product code FGE
- Device class
- Class 2
- Regulation
- 21 CFR 876.5010
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Traditional
- Location
- Elkton, MD, US
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More clearances from W. L. Gore & Associates, Inc.
view allAdverse 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 K170740
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K170740.
Data sourced from openFDA. This site is unofficial and independent of the FDA.