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)

Q: What is the product code of K251700?

The FDA product code is QSY – Hemostatic Wound Dressing Without Thrombin Or Other Biologics, a Unclassified device.

FDA 510(k) K251700 · Speciality Fibres and Materials Limited

Substantially Equivalent

510(k) numberK251700

Submission

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)
Applicant: Speciality Fibres and Materials Limited
Coventry, GB
Received: June 2, 2025
Decision date: February 26, 2026
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: QSY – Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Device class: Unclassified

To temporarily control bleeding and cover external wounds.

Other 510(k)s with product code QSY

510(k)	Device	Applicant	Decision
K253017	BloodSTOP iX Trauma Matrix (TM-iX-20)QSY · Traditional	Lifescience Plus, Inc.	04/30/2026SE
K250319	Mfuse (MS001)QSY · Traditional	Machina Medical, Inc.	12/15/2025SE
K253609	TRAUMAGEL® 2.0 Hemostatic GelQSY · Special	Cresilon, Inc.	12/12/2025SE
K240713	Traumagel®QSY · Traditional	Cresilon, Inc.	08/14/2024SE
K240097	Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5)QSY · Traditional	Ushare Medical, Inc.	05/22/2024SE
K232216	Hemoblock_S (Prescription); Hemoblock_S (OTC)QSY · Traditional	Incore Co., Ltd.	04/19/2024SE
K240454	RESPONDER® Polysaccharide HemostatQSY · Special	Starch Medical, Inc.	03/15/2024SE
K220525	RESPONDER Polysaccharide HemostatQSY · Traditional	Starch Medical, Inc.	12/04/2023SE
K230589	Celox Rapid X-Ray GauzeQSY · Traditional	Medtrade Products , Ltd.	11/17/2023SE
K213413	Hemostatic DressingQSY · Traditional	Jiangsu Newvalue Medical Products Co., Ltd.	09/01/2023SE

More from Jiangsu Newvalue Medical Products Co., Ltd.

510(k)	Device	Decision
K222740	Venus Ag 120, 160, 200 2x2 inch, Venus Ag 120, 160, 200 4x4 inch, Venus Ag 120, 160, 200…FRO · Traditional	10/21/2024SE
K183208	Suprasorb A + Ag RFRO · Traditional	08/15/2019SE

Questions and answers

When was 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) cleared by the FDA?

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) (K251700) received a 510(k) decision of Substantially Equivalent on February 26, 2026, 269 days after the submission was received.

What is the product code of K251700?

The FDA product code is QSY – Hemostatic Wound Dressing Without Thrombin Or Other Biologics, a Unclassified device.