Data / Medical devices / United States / Bechtel Medical Inc
Bechtel Medical Inc: FDA-registered device maker in Phoenixville, PA, United States, 1 510(k) clearance
Bechtel Medical Inc is registered with the FDA (registration 3043172326) in Phoenixville, PA, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated May 4, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3043172326
- Address
- 300 Schell Ln Ste 305, Phoenixville, PA, United States, 19460
- Owner or operator
- Bechtel Medical Inc (10096276)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- August 19, 2026
- Registered through
- 2026
- Brand names listed
- Wound Geni
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dressing, Wound, Occlusive | NAD | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Negative Pressure Wound Therapy Powered Suction Pump | OMP | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 4, 2026 | K254019 | Wound Geni NPWT System | OMP | Substantially Equivalent | Bechtel Medical, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Negative Pressure Wound Therapy Powered Suction Pump
- All makers of Dressing, Wound, Occlusive
Updated May 4, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.