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
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2026
Decision
269d
Days
-
Risk

K251700 is an FDA 510(k) clearance for the Ganymede 2cm diameter (FG100300). Classified as Hemostatic Wound Dressing Without Thrombin Or Other Biologics (product code QSY).

Submitted by Speciality Fibres and Materials Limited (Coventry, GB). The FDA issued a Cleared decision on February 26, 2026 after a review of 269 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Speciality Fibres and Materials Limited devices

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
155d slower than avg
Panel avg: 114d · This submission: 269d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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

Regulatory Consultant

Compliance Solutions, Inc.
Angela Paterson

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics

All 126
Devices cleared under the same product code (QSY) and FDA review panel - the closest regulatory comparables to K251700.
BloodSTOP iX Trauma Matrix (TM-iX-20)
K253017 · Lifescience Plus, Inc. · Apr 2026
MFUSE (MS001)
K250319 · Machina Medical, Inc. · Dec 2025
TRAUMAGEL® 2.0 Hemostatic Gel
K253609 · Cresilon, Inc. · Dec 2025
TRAUMAGEL®
K240713 · Cresilon, Inc. · Aug 2024
Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5)
K240097 · Ushare Medical, Inc. · May 2024
Hemoblock_S (Prescription)
K232216 · Incore Co., Ltd. · Apr 2024