GENERAL SURGERY TRAY— 510(k) K842648

Substantially Equivalent

Deroyal Industries, Inc.

FDA 510(k) clearance K842648 for GENERAL SURGERY TRAY, Substantially Equivalent on 1984-09-20. Applicant: Deroyal Industries, Inc..

Clearance details

Applicant: Deroyal Industries, Inc.
Product code: Code LRO
Advisory panel: General, Plastic Surgery
Date received: 1984-08-13
Decision date: 1984-09-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Powell, 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.