STRYKER ENCORE STERILIZER— 510(k) K962755

Substantially Equivalent

Stryker Corp.

FDA 510(k) clearance K962755 for STRYKER ENCORE STERILIZER, Substantially Equivalent on 1997-03-04. Applicant: Stryker Corp..

Clearance details

Applicant: Stryker Corp.
Product code: Code FLE
Advisory panel: General Hospital
Date received: 1996-07-16
Decision date: 1997-03-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kalamazoo, MI, US

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Adverse events under product code FLE

product code FLE

Malfunction: 444
Total: 444

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.