ZIMMER A.T.S. 4000TS AUTOMATIC TOURNIQUET SYSTEM— 510(k) K123553

Substantially Equivalent

Zimmer, Inc.

FDA 510(k) clearance K123553 for ZIMMER A.T.S. 4000TS AUTOMATIC TOURNIQUET SYSTEM, Substantially Equivalent on 2013-08-09. Applicant: Zimmer, Inc..

Clearance details

Applicant: Zimmer, Inc.
Product code: Code KCY
Advisory panel: General, Plastic Surgery
Date received: 2012-11-19
Decision date: 2013-08-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianpolis, IN, US

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Adverse events under product code KCY

product code KCY

Malfunction: 868
Total: 868

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.