STRYKER STRYKEFLOW SUCTION IRRIGATOR (MODIFICATION)— 510(k) K954726

Substantially Equivalent

Stryker Endoscopy

FDA 510(k) clearance K954726 for STRYKER STRYKEFLOW SUCTION IRRIGATOR (MODIFICATION), Substantially Equivalent on 1995-11-29. Applicant: Stryker Endoscopy.

Clearance details

Applicant: Stryker Endoscopy
Product code: Code GCX
Advisory panel: General Hospital
Date received: 1995-08-03
Decision date: 1995-11-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Clara, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GCX

product code GCX

Death: 9
Malfunction: 592
Other: 2
Total: 603

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.