Ganymede 2cm diameter (FG100300) +14 more— 510(k) K251700

Name: FDA 510(k) clearance K251700
Creator: U.S. Food and Drug Administration
Published: 2026-02-26

Substantially Equivalent

Speciality Fibres and Materials Limited

FDA 510(k) clearance K251700 for Ganymede 2cm diameter (FG100300) +14 more, Substantially Equivalent on 2026-02-26. Applicant: Speciality Fibres and Materials Limited. Device class: Unclassified.

Summary

Speciality Fibres and Materials lists nine Ganymede sizes (from 2cm diameter to 40cm x 40cm, plus 7.5cm x 120cm) and then Ganymede-X sizes, with FG numbers in parentheses. The device name is cut off partway through the Ganymede-X list. It's filed under product code QSY, hemostatic wound dressing without thrombin or other biologics.

Class U, with no regulation number. The classification panel is listed as Unknown, and the General, Plastic Surgery review panel handled it as a Traditional 510(k).

Speciality Fibres and Materials filed from Coventry, United Kingdom. The decision came 269 calendar days after FDA received it (June 2, 2025 to February 26, 2026), and it was substantially equivalent.

Clearance details

Device name as filed: 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
Product code: Product code QSY
Device class: Unclassified
Advisory panel: Unknown
Date received: 2025-06-02
Decision date: 2026-02-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Coventry, GB

Download summary PDF View on FDA.gov ↗

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K253609 — TRAUMAGEL® 2.0 Hemostatic Gel2025-12-12
K240713 — TRAUMAGEL®2024-08-14
K240097 — Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5)2024-05-22

Adverse events under product code QSY

product code QSY

Death: 5
Other: 1
Total: 6

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.