SURGICAL DRAPE KIT - D.I.R.R.A. SRL— 510(k) K041080

Substantially Equivalent

D.I.R.R.A. S.R.L.

FDA 510(k) clearance K041080 for SURGICAL DRAPE KIT - D.I.R.R.A. SRL, Substantially Equivalent on 2004-11-30. Applicant: D.I.R.R.A. S.R.L..

Clearance details

Applicant: D.I.R.R.A. S.R.L.
Product code: Code LRO
Advisory panel: General, Plastic Surgery
Date received: 2004-04-26
Decision date: 2004-11-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Viadana, Mantova, IT

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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.