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
Product code	QSY
Device class	Class U
Decision date	Feb 26, 2026
Decision	Substantially Equivalent
Regulation	—

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

Ganymede and Ganymede-X are hemostatic dressings intended to stop bleeding from wounds. Over-the-counter use is for superficial wounds, minor cuts, and abrasions; prescription use is for moderately to severely bleeding wounds including surgical and traumatic injuries. The devices are non-exothermic, fast-acting, and highly absorbent.

Technological characteristics

Ganymede consists of purified clinoptilolite tuff in calcium alginate fibers blended with carboxymethyl cellulose and lyocell fibers. Ganymede-X includes an additional radiopaque yarn for X-ray visibility. The predicate QuikClot uses kaolin clay bound to medical gauze with glycerin. Both use medical-grade non-woven fabric with hemostatic agents, sterilized by gamma irradiation, with a maximum use period of 72 hours for Ganymede and 24 hours for QuikClot.

Test standards cited

ASTM D4169-23, ASTM D4332-22, ASTM F1886, ASTM F1929, ASTM F88, BS EN ISO 13726, and ISO 10993-1 for biocompatibility evaluation including cytotoxicity, sensitization, irritation, acute systemic toxicity, and hemocompatibility testing.

Substantial equivalence argument

Ganymede and Ganymede-X are substantially equivalent to QuikClot because they share the same intended use, indications, product code (QSY), and classification. Despite differences in material composition (alginate-based vs. kaolin-based), both devices employ medical-grade non-woven fabric with hemostatic agents and achieve comparable safety and efficacy, as demonstrated by bench testing and animal studies showing no adverse indications.

Extracted by AI from the official FDA summary PDF →

Source

View the full FDA submission: accessdata.fda.gov

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