STRYKER WIRELESS UNIVERSAL FOOTSWITCH SYSTEM— 510(k) K033135

Substantially Equivalent

Stryker Endoscopy

FDA 510(k) clearance K033135 for STRYKER WIRELESS UNIVERSAL FOOTSWITCH SYSTEM, Substantially Equivalent on 2004-08-09. Applicant: Stryker Endoscopy.

Clearance details

Applicant: Stryker Endoscopy
Product code: Code KNS
Advisory panel: Gastroenterology, Urology
Date received: 2003-09-30
Decision date: 2004-08-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Jose, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KNS

product code KNS

Death: 44
Injury: 2,361
Malfunction: 4,771
Total: 7,176

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.