CURITY IRRIGATION TRAY— 510(k) K771079

Substantially Equivalent

Kendall Research Center

FDA 510(k) clearance K771079 for CURITY IRRIGATION TRAY, Substantially Equivalent on 1977-09-15. Applicant: Kendall Research Center.

Clearance details

Applicant: Kendall Research Center
Product code: Code GBX
Advisory panel: General, Plastic Surgery
Date received: 1977-06-15
Decision date: 1977-09-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GBX

product code GBX

Death: 16
Injury: 583
Malfunction: 3,578
Other: 1
Total: 4,178

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.