NewEra Small REVA Kit, NewEra Medium REVA Kit, NewEra Large REVA Kit— 510(k) K143301
Substantially EquivalentIntegrated 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. Device class: 2.
Clearance details
- Applicant
- Integrated Healing Technologies
- Product code
- Product code OMP
- Device class
- Class 2
- Regulation
- 21 CFR 878.4780
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Franklin, TN, US
Recent devices under product code OMP
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- K260426 — MeCare Alpha (MCA2019)
- K261338 — RENASYS DYNAFLOW Kit (66807741)
- K253263 — ConvaVAC Negative Pressure Wound Therapy System
More clearances from Integrated Healing Technologies
view allAdverse 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, through . 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.