Data / Medical devices / United Kingdom / Prosys International Ltd
Prosys International Ltd: FDA-registered device maker in London London, City of, United Kingdom, 1 510(k) clearance
Prosys International Ltd is registered with the FDA (registration 3005533818) in London London, City of, United Kingdom. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated March 13, 2020. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3005533818
- Address
- Suite 4 2 Allington Close; Wimbledon; England, London London, City of, United Kingdom, SW19 5AP
- Owner or operator
- Prosys International Ltd (10048819)
- Roles
- Exporter to the US, Specification developer
- First device listed
- July 2, 2021
- Registered through
- 2027
- Brand names listed
- Avantgarde +T, Offload Bootee, Prevasse
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cushion, Flotation | KIC | 1 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Protector, Skin Pressure | FMP | 1 | Exporter to the US, Specification developer | accessdata.fda.gov |
| Tubes, Gastrointestinal (And Accessories) | KNT | 2 | Exporter to the US, Specification developer | 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 |
|---|---|---|---|---|---|---|
| March 13, 2020 | K193325 | Avantgarde Faecal Management Systems, Avantgarde Faecal Management System Replacement Pouches | KNT | Substantially Equivalent | Prosys International, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Protector, Skin Pressure
- All makers of Tubes, Gastrointestinal (And Accessories)
- All makers of Cushion, Flotation
Updated March 13, 2020. 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.