XLR8 Abdominal Wound Dressing Kit— 510(k) K182722

Name: FDA 510(k) clearance K182722
Creator: U.S. Food and Drug Administration
Published: 2019-09-27

Substantially Equivalent

Genadyne Biotechnologies

FDA 510(k) clearance K182722 for XLR8 Abdominal Wound Dressing Kit, Substantially Equivalent on 2019-09-27. Applicant: Genadyne Biotechnologies. Device class: 2.

Clearance details

Applicant: Genadyne Biotechnologies
Product code: Code OMP
Device class: Class 2
Regulation: 21 CFR 878.4780
Advisory panel: General, Plastic Surgery
Date received: 2018-09-28
Decision date: 2019-09-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hicksville, NY, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code OMP

product code OMP

Death: 31
Injury: 1,707
Malfunction: 4,047
Other: 1
Total: 5,786

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.