Product code QSY
- Device name
- Hemostatic Wound Dressing Without Thrombin Or Other Biologics
- Medical specialty
- Unknown
- Device class
- U
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- To temporarily control bleeding and cover external wounds.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253017 | BloodSTOP iX Trauma Matrix (TM-iX-20) | Lifescience Plus, Inc. | 2026-04-30 |
| K251700 | 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); Ganymed... | Speciality Fibres and Materials Limited | 2026-02-26 |
| K250319 | MFUSE (MS001) | Machina Medical, Inc. | 2025-12-15 |
| K253609 | TRAUMAGEL® 2.0 Hemostatic Gel | Cresilon, Inc. | 2025-12-12 |
| K240713 | TRAUMAGEL® | Cresilon, Inc. | 2024-08-14 |
| K240097 | Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5) | Ushare Medical, Inc. | 2024-05-22 |
| K232216 | Hemoblock_S (Prescription); Hemoblock_S (OTC) | Incore Co., Ltd. | 2024-04-19 |
| K240454 | RESPONDER® Polysaccharide Hemostat | Starch Medical, Inc. | 2024-03-15 |
| K220525 | RESPONDER Polysaccharide Hemostat | Starch Medical, Inc. | 2023-12-04 |
| K230589 | Celox Rapid X-Ray Gauze | Medtrade Products , Ltd. | 2023-11-17 |
| K213413 | Hemostatic Dressing | Jiangsu Newvalue Medical Products Co., Ltd. | 2023-09-01 |
| K213652 | Cresilon Hemostatic Gel, CHG, Cresilon Hemostatic Gel (CHG) | Cresilon, Inc. | 2023-06-28 |
| K223495 | Zeolite Hemostatic Cotton | Hangzhou Zeo-Innov Life Technology Co., Ltd. | 2023-05-02 |
| K222909 | Axiostat Gauze | Advamedica, Inc. | 2023-04-07 |
| K210751 | S.E.A.L. Hemostatic Wound Spray | Bc3 Technologies, Inc. | 2023-02-02 |
| K220566 | Vascette HP (hemostatic pad) | Koag, LLC | 2022-07-29 |
| K211570 | Zeolite Hemostatic Gauze | Hangzhou Zeo-Innov Life Technology Co., Ltd. | 2022-02-10 |
| K202830 | Axiostat Patch | Advamedica, Inc. | 2021-04-15 |
| K192671 | Hemostatic Xerogel Sponge | Solaplus Biotech Co., Ltd. | 2020-08-28 |
| K190012 | OMNI-STAT Vascular (Rapid); CELOX Vascular Rapid | Medtrade Product, Ltd. | 2019-12-18 |
| K183622 | NasalCEASE and BleedCEASE | Les Laboratoires Brothier S.A. | 2019-12-02 |
| K192667 | gel-e Flex+ gel OTC | Gel-E, Inc. | 2019-10-25 |
| K182811 | gel-e Flex+ | Gel-E, Inc. | 2019-08-29 |
| K181641 | QuikClot Radial | Z-Medica, LLC | 2018-12-24 |
| K180893 | IHM Technology Bandage | Protege Biomedical | 2018-09-19 |
| K180152 | gel-e Flex | Gel-E, Inc. | 2018-06-22 |
| K172155 | StatGuard Hemostatic Patch, StatGuard Hemostatic Dressing | Statguard, LLC | 2018-04-12 |
| K172324 | Axiostat Chitosan Hemostatic Dressing | Advamedica, Inc. | 2018-02-23 |
| K161274 | Bondiloxs Topical Hemostatic Granules | Medtrade Products , Ltd. | 2017-01-18 |
| K161013 | InnoSEAL Hemostatic Pad | Innotherapy, Inc. | 2016-11-29 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00860007891168 | TRAUMAGEL® | Cresilon, Inc. | 2026-06-01 |
| 00017276241709 | Rapid Seal | Aso LLC | 2026-05-27 |
| 10841495149679 | QUIKCLOT | TELEFLEX INCORPORATED | 2026-05-11 |
| 14026704935892 | QUIKCLOT | TELEFLEX INCORPORATED | 2026-04-09 |
| 10841495149648 | QUIKCLOT | TELEFLEX INCORPORATED | 2026-04-09 |
| 14026704930163 | QUIKCLOT | TELEFLEX INCORPORATED | 2026-03-20 |
| 14026704930149 | QUIKCLOT | TELEFLEX INCORPORATED | 2026-03-20 |
| 10841495150385 | QUIKCLOT | TELEFLEX INCORPORATED | 2026-03-20 |
| 14026704930101 | QUIKCLOT | TELEFLEX INCORPORATED | 2026-03-20 |
| 10841495150408 | QUIKCLOT | TELEFLEX INCORPORATED | 2026-03-20 |
| 10841495150422 | QUIKCLOT | TELEFLEX INCORPORATED | 2026-03-20 |
| 10841495150446 | QUIKCLOT | TELEFLEX INCORPORATED | 2026-03-20 |
| 14026704930088 | QUIKCLOT | TELEFLEX INCORPORATED | 2026-03-20 |
| 10841495149532 | QUIKCLOT | TELEFLEX INCORPORATED | 2026-01-13 |
| 10841495149556 | QUIKCLOT | TELEFLEX INCORPORATED | 2026-01-13 |
| 10841495149570 | QUIKCLOT | TELEFLEX INCORPORATED | 2026-01-13 |
| 10841495149617 | QUIKCLOT | TELEFLEX INCORPORATED | 2026-01-13 |
| 14026704930712 | QUIKCLOT | TELEFLEX INCORPORATED | 2025-11-04 |
| 10841495149525 | QUIKCLOT | TELEFLEX INCORPORATED | 2025-11-04 |
| 10841495150439 | QUIKCLOT | TELEFLEX INCORPORATED | 2025-09-26 |
| 10841495150453 | QUIKCLOT | TELEFLEX INCORPORATED | 2025-09-26 |
| 10841495150392 | QUIKCLOT | TELEFLEX INCORPORATED | 2025-09-26 |
| 10841495149594 | QUIKCLOT | TELEFLEX INCORPORATED | 2025-09-18 |
| 10860008863307 | BleedCEASE® | Carencease Healthcare LLC | 2024-12-10 |
| 10860008863314 | BleedCEASE® | Carencease Healthcare LLC | 2024-12-10 |
| 10860008863321 | BleedCEASE® | Carencease Healthcare LLC | 2024-12-10 |
| 10860008863338 | NasalCEASE® | Carencease Healthcare LLC | 2024-12-10 |
| 10193489141900 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2024-07-25 |
| 10193489141894 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2024-07-16 |
| 10815614020804 | StatGuard Hemostatic Patch | Semler Technologies, Inc. | 2019-08-07 |