WILSON-COOK BALLOON INFLATION DEVICE— 510(k) K936168

Substantially Equivalent

Wilson-Cook Medical, Inc.

FDA 510(k) clearance K936168 for WILSON-COOK BALLOON INFLATION DEVICE, Substantially Equivalent on 1994-03-28. Applicant: Wilson-Cook Medical, Inc..

Clearance details

Applicant: Wilson-Cook Medical, Inc.
Product code: Code KNT
Advisory panel: Gastroenterology, Urology
Date received: 1993-12-23
Decision date: 1994-03-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Winston-Salem, NC, US

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Adverse events under product code KNT

product code KNT

Death: 192
Injury: 6,034
Malfunction: 4,049
Other: 1
Total: 10,276

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.