Data / Medical devices / United Kingdom / Speciality Fibres and Materials Limited
Speciality Fibres and Materials Limited: FDA-registered device maker in Coventry, United Kingdom, 4 510(k) clearances
Speciality Fibres and Materials Limited is registered with the FDA (registration 3005818605) in Coventry, United Kingdom. It lists 3 device types. The FDA files 4 510(k) clearances under its listings, the newest dated February 26, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005818605
- Address
- Galaxy House - 31 Herald Way Binley Industrial Estate, Coventry, United Kingdom, CV3 2RQ
- Owner or operator
- Speciality Fibres and Materials Limited (10021853)
- Roles
- Complaint file establishment, Contract manufacturer, Contract sterilizer, Manufacturer
- First device listed
- October 3, 2007
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dressing, Wound, Drug | FRO | U | Complaint file establishment, Contract manufacturer, Contract sterilizer, Manufacturer | accessdata.fda.gov |
| Dressing, Wound, Hydrophilic | NAC | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Hemostatic Wound Dressing Without Thrombin Or Other Biologics | QSY | U | 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 26, 2026 | K251700 | Ganymede 2cm diameter (FG100300); Ganymede 5cm x 5cm (FG100400); Ganymede 10cm x 10cm (FG100500); Ganymede 15cm x 15cm (FG100600); Ganymede 20cm x 30cm (FG100700); Ganymede 25cm x 25cm (FG100800); Ganymede 30cm x 30cm (FG100900); Ganymede 40cm x 40cm (FG100999); Ganymede 7.5cm x 120cm (FG100100); Ganymede-X 2cm diameter (FG100301); Ganymede-X 5cm x 5cm (FG100401); Ganymede-X 10cm x 10cm (FG100501); Ganymede-X 15cm x 15cm (FG100601); Ganymede-X 20cm x 30cm (FG100701); Ganymede-X 25cm | QSY | Substantially Equivalent | Speciality Fibres and Materials Limited | accessdata.fda.gov |
| October 21, 2024 | K222740 | Venus Ag 120, 160, 200 2x2 inch, Venus Ag 120, 160, 200 4x4 inch, Venus Ag 120, 160, 200 4x5 inch, Venus Ag 120, 160, 200 6x6 inch,Venus Ag 120, 160, 200 1x18 inch | FRO | Substantially Equivalent | Speciality Fibres and Materials, Ltd. | accessdata.fda.gov |
| August 15, 2019 | K183208 | Suprasorb A + Ag R | FRO | Substantially Equivalent | Speciality Fibres and Materials, Ltd. | accessdata.fda.gov |
| May 1, 2008 | K071442 | SUPRASORB A +AG | FRO | Substantially Equivalent | Specialty Fibres and Materials, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Hemostatic Wound Dressing Without Thrombin Or Other Biologics
- All makers of Dressing, Wound, Drug
- All makers of Dressing, Wound, Hydrophilic
Updated February 26, 2026. 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.