Data / Medical devices / United States / Bioseal
Bioseal: FDA-registered device maker in Grapevine, TX, United States, 1 510(k) clearance
Bioseal is registered with the FDA (registration 3043620414) in Grapevine, TX, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated August 10, 1989. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3043620414
- Address
- 801 Industrial Blvd Ste 100, Grapevine, TX, United States, 76051
- Owner or operator
- BIOSEAL (2027062)
- Roles
- Manufacturer
- First device listed
- November 9, 2007
- Registered through
- 2027
- Brand names listed
- Surgery Kit
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| General Surgery Tray | LRO | 2 | 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 |
|---|---|---|---|---|---|---|
| August 10, 1989 | K893814 | SURGICAL INSTRUMENT KIT, DISPOSABLE | LRO | Substantially Equivalent | Bioseal | accessdata.fda.gov |
Compare with other makers
Updated August 10, 1989. 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.