Data / Medical devices / United States / WestBridge Vocational, Inc.
WestBridge Vocational, Inc.: FDA-registered device maker in Sylva, NC, United States, 2 510(k) clearances
WestBridge Vocational, Inc. is registered with the FDA (registration 1034084) in Sylva, NC, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated April 27, 2005. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 1034084
- Address
- 140 Little Savannah Rd, Sylva, NC, United States, 28779
- Owner or operator
- WestBridge Vocational, Inc (1034084)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- January 30, 2013
- Registered through
- 2026
- Brand names listed
- CK, CPN, Roo Defender Catheter Cover, WECARE
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Drape, Surgical, Antimicrobial | KKX | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Garment, Storage, Peritoneal Dialysis Catheter | OAG | 1 | Contract 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 |
|---|---|---|---|---|---|---|
| April 27, 2005 | K050508 | HVO, INC., DISPOSABLE NON-STERILE SURGICAL DRAPES | KKX | Substantially Equivalent | Haywood Vocational Opportunities | accessdata.fda.gov |
| January 20, 1987 | K864899 | SURGICAL DRAPE PACK | KKX | Substantially Equivalent | Webster Enterprises, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Garment, Storage, Peritoneal Dialysis Catheter
- All makers of Drape, Surgical, Antimicrobial
Updated April 27, 2005. 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.