About This 510(k) Submission
K251700 is an FDA 510(k) clearance for the 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, a Hemostatic Wound Dressing Without Thrombin Or Other Biologics, submitted by Speciality Fibres and Materials Limited (Coventry, GB). The FDA issued a Cleared decision on February 26, 2026, 269 days after receiving the submission on June 2, 2025. This device falls under the General & Plastic Surgery review panel.