INNERDYNE RADIALLY EXPANDING DILATION, RED DEVICE— 510(k) K990854

Substantially Equivalent

Innerdyne, Inc.

FDA 510(k) clearance K990854 for INNERDYNE RADIALLY EXPANDING DILATION, RED DEVICE, Substantially Equivalent on 1999-08-02. Applicant: Innerdyne, Inc..

Clearance details

Applicant: Innerdyne, Inc.
Product code: Code FGE
Advisory panel: Gastroenterology, Urology
Date received: 1999-03-15
Decision date: 1999-08-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, 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.