VORTEK URETERAL DOUBLE LOOP STENT, BIOSOFT URETERAL DOUBLE LOOP STENT— 510(k) K981591

Substantially Equivalent

International Regulatory Consultants

FDA 510(k) clearance K981591 for VORTEK URETERAL DOUBLE LOOP STENT, BIOSOFT URETERAL DOUBLE LOOP STENT, Substantially Equivalent on 1998-10-09. Applicant: International Regulatory Consultants.

Clearance details

Applicant: International Regulatory Consultants
Product code: Code FAD
Advisory panel: Gastroenterology, Urology
Date received: 1998-05-04
Decision date: 1998-10-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Salt Lake City, UT, US

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Adverse events under product code FAD

product code FAD

Death: 2
Injury: 858
Malfunction: 2,651
Other: 1
Total: 3,512

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.