SULLIVAN VARIABLE STIFFNESS CABLE— 510(k) K901610

Substantially Equivalent

Wilson-Cook Medical, Inc.

FDA 510(k) clearance K901610 for SULLIVAN VARIABLE STIFFNESS CABLE, Substantially Equivalent on 1990-06-29. Applicant: Wilson-Cook Medical, Inc..

Clearance details

Applicant: Wilson-Cook Medical, Inc.
Product code: Code FDF
Advisory panel: Gastroenterology, Urology
Date received: 1990-04-06
Decision date: 1990-06-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Winston-Salem, NC, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FDF

product code FDF

Death: 8
Injury: 729
Malfunction: 61,773
Total: 62,510

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.