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QSY — Hemostatic Wound Dressing Without Thrombin Or Other Biologics Class U

FDA Device Classification

Classification Details

Product Code
QSY
Device Class
Class U
Regulation Number
Submission Type
Review Panel
SU
Medical Specialty
Unknown
Implant
No

Definition

To temporarily control bleeding and cover external wounds.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K251700speciality fibres and materials limitedGanymede 2cm diameter (FG100300); Ganymede 5cm x 5cm (FG100400); Ganymede 10cm xFebruary 26, 2026
K250319machina medicalMFUSE (MS001)December 15, 2025
K253609cresilonTRAUMAGEL® 2.0 Hemostatic GelDecember 12, 2025
K240713cresilonTRAUMAGEL®August 14, 2024
K240097ushare medicalPolysaccharide Hemostatic Powder (HP-2, HP-3, HP-5)May 22, 2024
K232216incore coHemoblock_S (Prescription); Hemoblock_S (OTC)April 19, 2024
K240454starch medicalRESPONDER® Polysaccharide HemostatMarch 15, 2024
K220525starch medicalRESPONDER Polysaccharide HemostatDecember 4, 2023
K230589medtrade productsCelox Rapid X-Ray GauzeNovember 17, 2023
K213413jiangsu newvalue medical products coHemostatic DressingSeptember 1, 2023
K213652cresilonCresilon Hemostatic Gel, CHG, Cresilon Hemostatic Gel (CHG)June 28, 2023
K223495hangzhou zeo-innov life technology coZeolite Hemostatic CottonMay 2, 2023
K222909advamedicaAxiostat GauzeApril 7, 2023
K210751bc3 technologiesS.E.A.L. Hemostatic Wound SprayFebruary 2, 2023
K220566koagVascette HP (hemostatic pad)July 29, 2022
K211570hangzhou zeo-innov life technology coZeolite Hemostatic GauzeFebruary 10, 2022
K202830advamedicaAxiostat PatchApril 15, 2021
K192671solaplus biotech coHemostatic Xerogel SpongeAugust 28, 2020
K190012medtrade productOMNI-STAT Vascular (Rapid); CELOX Vascular RapidDecember 18, 2019
K183622les laboratoires brothierNasalCEASE and BleedCEASEDecember 2, 2019