OPTOSSOL COMPRESSION DEVICE SYSTEM— 510(k) K140875

Substantially Equivalent

Genossis, LLC

FDA 510(k) clearance K140875 for OPTOSSOL COMPRESSION DEVICE SYSTEM, Substantially Equivalent on 2014-05-30. Applicant: Genossis, LLC.

Clearance details

Applicant: Genossis, LLC
Product code: Code JDW
Advisory panel: Orthopedic
Date received: 2014-04-04
Decision date: 2014-05-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newburyport, MA, US

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Adverse events under product code JDW

product code JDW

Injury: 717
Total: 717

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.