QSY
- Product code
- QSY
- Device name
- Hemostatic Wound Dressing Without Thrombin Or Other Biologics
- Device class
- Class U
- Medical specialty
- Unknown
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 10
- Summaries archived here
- 8 (direct download)
- 510(k) clearances (all years, FDA)
- 127 (all years; only the last 3 years are listed here)
FDA classification definition
To temporarily control bleeding and cover external wounds.
510(k) clearances, last 3 years (10)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K253017 | 2026-04-30 | Lifescience Plus, Inc. | BloodSTOP iX Trauma Matrix (TM-iX-20) | |
| K251700 | 2026-02-26 | Speciality Fibres and Materials Limite… | Ganymede 2cm diameter (FG100300); Ganymede 5cm x 5cm… | |
| K250319 | 2025-12-15 | Machina Medical, Inc. | MFUSE (MS001) | |
| K253609 | 2025-12-12 | Cresilon, Inc. | TRAUMAGEL® 2.0 Hemostatic Gel | |
| K240713 | 2024-08-14 | Cresilon, Inc. | TRAUMAGEL® | FDA |
| K240097 | 2024-05-22 | Ushare Medical, Inc. | Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5) | |
| K232216 | 2024-04-19 | Incore Co., Ltd. | Hemoblock_S (Prescription); Hemoblock_S (OTC) | FDA |
| K240454 | 2024-03-15 | Starch Medical, Inc. | RESPONDER® Polysaccharide Hemostat | |
| K220525 | 2023-12-04 | Starch Medical, Inc. | RESPONDER Polysaccharide Hemostat | |
| K230589 | 2023-11-17 | Medtrade Products , Ltd. | Celox Rapid X-Ray Gauze |
Official FDA classification page: QSY
Classification and pathway per current FDA publications. Data from openFDA (CC0).