Cleared Traditional

K251700 - Ganymede 2cm diameter (FG100300) (FDA 510(k) Clearance)

Also includes:
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
K251700 · Speciality Fibres and Materials Limited · General & Plastic Surgery device
Feb 2026
Decision
269d
Days
-
Risk

K251700 is an FDA 510(k) clearance for the Ganymede 2cm diameter (FG100300). This device is classified as 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 FDA review panel. To Temporarily Control Bleeding And Cover External Wounds..

Submission Details

510(k) Number K251700 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2025
Decision Date February 26, 2026
Days to Decision 269 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code QSY - Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Device Class -
Definition To Temporarily Control Bleeding And Cover External Wounds.