DISPOSABLE HEMOSTASIS CHIP— 510(k) K121505

Substantially Equivalent

Wilson-Cook Medical Inc./Cook Endoscopy

FDA 510(k) clearance K121505 for DISPOSABLE HEMOSTASIS CHIP, Substantially Equivalent on 2012-08-31. Applicant: Wilson-Cook Medical Inc./Cook Endoscopy.

Clearance details

Applicant: Wilson-Cook Medical Inc./Cook Endoscopy
Product code: Code PKL
Advisory panel: Gastroenterology, Urology
Date received: 2012-05-21
Decision date: 2012-08-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Winston-Salem, NC, US

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Adverse events under product code PKL

product code PKL

Death: 9
Injury: 489
Malfunction: 4,698
Other: 1
Total: 5,197

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.