OTW MEGALINK SDS BILLIARY STENT SYSTEM, MODELS 1005509-18, 1005510-18, 1005511-18, 1005512-18, 1005509-28, 1005510-28, 1— 510(k) K001222

Unknown

Guidant Corp.

FDA 510(k) clearance K001222 for OTW MEGALINK SDS BILLIARY STENT SYSTEM, MODELS 1005509-18, 1005510-18, 1005511-18, 1005512-18, 1005509-28, 1005510-28, 1, Unknown on 2000-05-17. Applicant: Guidant Corp..

Clearance details

Applicant: Guidant Corp.
Product code: Code FGE
Advisory panel: Gastroenterology, Urology
Date received: 2000-04-17
Decision date: 2000-05-17
Decision: Unknown
Clearance type: Special
Location: Santa Clara, CA, US

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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, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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