K251700
- 510(k) number
- K251700
- Device name
- 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
- Applicant
- Speciality Fibres and Materials Limited GB
- Product code
- QSY — Hemostatic Wound Dressing Without Thrombin Or Other
- Decision date
- 2026-02-26
- Date received
- 2025-06-02
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Unknown
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K251700.pdf
Official FDA record: K251700
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.