KENDALL TRU-CLOSE INFECTION CONTROL EVACUATOR— 510(k) K925989

Substantially Equivalent

Kendall Healthcare Products Co. Div.Of Tyco Health

FDA 510(k) clearance K925989 for KENDALL TRU-CLOSE INFECTION CONTROL EVACUATOR, Substantially Equivalent on 1993-02-26. Applicant: Kendall Healthcare Products Co. Div.Of Tyco Health.

Clearance details

Applicant: Kendall Healthcare Products Co. Div.Of Tyco Health
Product code: Code GCY
Advisory panel: General, Plastic Surgery
Date received: 1992-11-25
Decision date: 1993-02-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mansfield, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GCY

product code GCY

Malfunction: 786
Other: 1
Total: 787

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.