Genadyne ASTRA NPWT— 510(k) K253429
Substantially EquivalentGenadyne Biotechnologies, Inc.
FDA 510(k) clearance K253429 for Genadyne ASTRA NPWT, Substantially Equivalent on 2026-03-12. Applicant: Genadyne Biotechnologies, Inc.. Device class: 2.
Summary
Genadyne Biotechnologies' Genadyne ASTRA NPWT is filed under OMP, negative pressure wound therapy powered suction pumps. The record doesn't describe the pump beyond its name and that code name.
Class II, 21 CFR 878.4780. General and Plastic Surgery is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Genadyne Biotechnologies filed from Hicksville, New York. Review took 162 calendar days (October 1, 2025 to March 12, 2026).
Clearance details
- Applicant
- Genadyne Biotechnologies, Inc.
- 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
- Hicksville, NY, US
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- K253263 — ConvaVAC Negative Pressure Wound Therapy System
More clearances from Genadyne Biotechnologies, Inc.
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.