INVIROBLUNT CANNULA WITH AND WITHOUT EZ WINGS, MODELS 120522 AND 120022— 510(k) K083851

Substantially Equivalent

Inviro Medical Devices, Inc.

FDA 510(k) clearance K083851 for INVIROBLUNT CANNULA WITH AND WITHOUT EZ WINGS, MODELS 120522 AND 120022, Substantially Equivalent on 2009-05-15. Applicant: Inviro Medical Devices, Inc..

Clearance details

Applicant: Inviro Medical Devices, Inc.
Product code: Code LHI
Advisory panel: General Hospital
Date received: 2008-12-24
Decision date: 2009-05-15
Decision: Substantially Equivalent
Clearance type: Special
Location: Lawrenceville, GA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LHI

product code LHI

Injury: 207
Malfunction: 7,820
Other: 3
Total: 8,030

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.