IRRIGATION TRAY— 510(k) K935740

Substantially Equivalent

Cush Medical Products

FDA 510(k) clearance K935740 for IRRIGATION TRAY, Substantially Equivalent on 1994-02-22. Applicant: Cush Medical Products.

Clearance details

Applicant: Cush Medical Products
Product code: Code LRO
Advisory panel: General, Plastic Surgery
Date received: 1993-12-01
Decision date: 1994-02-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Piney Flats, TN, US

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Adverse events under product code LRO

product code LRO

Injury: 975
Malfunction: 14,038
Other: 2
Total: 15,015

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.