MODIFICATION TO RX HERCULINK 14 BILIARY STENT SYSTEM, MODELS 1005126-13, 1005128-13, 1005130-13, 1005132-13, 1005134-13,— 510(k) K993588

Substantially Equivalent

Guidant Corp.

FDA 510(k) clearance K993588 for MODIFICATION TO RX HERCULINK 14 BILIARY STENT SYSTEM, MODELS 1005126-13, 1005128-13, 1005130-13, 1005132-13, 1005134-13,, Substantially Equivalent on 1999-11-17. Applicant: Guidant Corp..

Clearance details

Applicant: Guidant Corp.
Product code: Code FGE
Advisory panel: Gastroenterology, Urology
Date received: 1999-10-22
Decision date: 1999-11-17
Decision: Substantially Equivalent
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.