Data / Medical devices / United States / Vonco Products, LLC
Vonco Products, LLC: FDA-registered device maker in Trevor, WI, United States, 2 510(k) clearances
Vonco Products, LLC is registered with the FDA (registration 1419562) in Trevor, WI, United States. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated July 10, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1419562
- Address
- 10826 250th Avenue, Trevor, WI, United States, 53179
- Owner or operator
- Vonco Products, LLC (10049262)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- May 4, 2015
- Registered through
- 2026
- Brand names listed
- EnteraLoc Flow, EnteraLoc Flow Spouted Pouch, VonSeal Chain of Custody, VonSeal Clear Mailer, Vonco 95kPa VonSeal, Vonco Biohazard Specimen Bag, Vonco Waterproof Shoe Covers
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Container, Specimen Mailer And Storage, Non-Sterile | NNK | 1 | Manufacturer | accessdata.fda.gov |
| Cover, Shoe, Operating-Room | FXP | 1 | Contract manufacturer | accessdata.fda.gov |
| Gastrointestinal Tubes With Enteral Specific Connectors | PIF | 2 | Manufacturer | accessdata.fda.gov |
| Pump, Infusion, Enteral | LZH | 2 | 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 |
|---|---|---|---|---|---|---|
| July 10, 2023 | K223683 | EnteraLoc Flow | PIF | Substantially Equivalent | Vonco Products | accessdata.fda.gov |
| August 18, 2021 | K210971 | EnteraLoc Flow | PIF | Substantially Equivalent | Vonco Products | accessdata.fda.gov |
Compare with other makers
- All makers of Cover, Shoe, Operating-Room
- All makers of Container, Specimen Mailer And Storage, Non-Sterile
- All makers of Gastrointestinal Tubes With Enteral Specific Connectors
- All makers of Pump, Infusion, Enteral
Updated July 10, 2023. 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.