PROTECTISCOPE CS COLONOSCOPE, NON-INTRAPULL— 510(k) K081004

Substantially Equivalent

Stryker GI

FDA 510(k) clearance K081004 for PROTECTISCOPE CS COLONOSCOPE, NON-INTRAPULL, Substantially Equivalent on 2008-05-02. Applicant: Stryker GI.

Clearance details

Applicant: Stryker GI
Product code: Code FDF
Advisory panel: Gastroenterology, Urology
Date received: 2008-04-08
Decision date: 2008-05-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Flower Mound, TX, US

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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.