Data / Medical devices / United States / Biowy Corporation
Biowy Corporation: FDA-registered device maker in Lake Forest, CA, United States, 3 510(k) clearances
Biowy Corporation is registered with the FDA (registration 3013233645) in Lake Forest, CA, United States. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated February 16, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013233645
- Address
- 27031 Vista Terrace, Lake Forest, CA, United States, 92630
- Owner or operator
- Biowy Corporation (10057786)
- Roles
- Manufacturer, Specification developer
- First device listed
- May 25, 2018
- Registered through
- 2026
- Brand names listed
- Biowy Corporation, Biowy Freezing Bag (FB50, FB250, FB500, FB1000), Biowy Multi-Chamber Freezing Bag (FB5x7, FB5x5), Biowy Multi-Chamber Freezing Bag Set (FP5x7, FB5x5), Biowy PICC-S Kit, Biowy Tym Tube
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | LJS | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Container, Frozen Donor Tissue Storage | LPZ | U | Manufacturer | accessdata.fda.gov |
| Tube, Tympanostomy | ETD | 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 |
|---|---|---|---|---|---|---|
| February 16, 2024 | K233658 | Biowy Tym Tube (TT) | ETD | Substantially Equivalent | Biowy Corporation | accessdata.fda.gov |
| April 30, 2020 | K192246 | Biowy PICC Catheter S Kit | LJS | Substantially Equivalent | Biowy Corporation | accessdata.fda.gov |
| May 21, 2018 | K173956 | Biowy PlCC Catheter | LJS | Substantially Equivalent | Biowy Corporation | accessdata.fda.gov |
Compare with other makers
- All makers of Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
- All makers of Container, Frozen Donor Tissue Storage
- All makers of Tube, Tympanostomy
Updated February 16, 2024. 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.