NewEra Small REVA Kit, NewEra Medium REVA Kit, NewEra Large REVA Kit— 510(k) K143301

Substantially Equivalent

Integrated Healing Technologies

FDA 510(k) clearance K143301 for NewEra Small REVA Kit, NewEra Medium REVA Kit, NewEra Large REVA Kit, Substantially Equivalent on 2015-03-03. Applicant: Integrated Healing Technologies.

Clearance details

Applicant: Integrated Healing Technologies
Product code: Code OMP
Advisory panel: General, Plastic Surgery
Date received: 2014-11-17
Decision date: 2015-03-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Franklin, TN, US

Download summary PDF View on FDA.gov ↗

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.