SYSTEC 280 INTEGRATED SUCTION SYSTEM— 510(k) K791349

Substantially Equivalent

Stryker Corp.

FDA 510(k) clearance K791349 for SYSTEC 280 INTEGRATED SUCTION SYSTEM, Substantially Equivalent on 1979-09-07. Applicant: Stryker Corp..

Clearance details

Applicant: Stryker Corp.
Product code: Code BTA
Advisory panel: General, Plastic Surgery
Date received: 1979-07-16
Decision date: 1979-09-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code BTA

product code BTA

Death: 5
Total: 5

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.