510(k) K253609

Device
TRAUMAGEL® 2.0 Hemostatic Gel
Applicant
Cresilon, Inc.
510(k) number
K253609
Product code
QSY
Decision
Substantially Equivalent (SESE)
Decision date
2025-12-12
Date received
2025-11-18
Classification name
Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Medical specialty
Unknown
Review panel
Unknown
Device class
U
Clearance type
Special
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Hassaan Ahmad
Address
86 34th St. Suite D603/D604 Brooklyn NY US 11232 11232

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code QSY#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K253017BloodSTOP iX Trauma Matrix (TM-iX-20)Lifescience Plus, Inc.2026-04-30
K251700Ganymede 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); Ganymede-X 15cm x 15cm (FG100601); Ganymede-X 20cm x 30cm (FG100701); Ganymede-X 25cmSpeciality Fibres and Materials Limited2026-02-26
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K230589Celox Rapid X-Ray GauzeMedtrade Products , Ltd.2023-11-17
K213413Hemostatic DressingJiangsu Newvalue Medical Products Co., Ltd.2023-09-01
K213652Cresilon Hemostatic Gel, CHG, Cresilon Hemostatic Gel (CHG)Cresilon, Inc.2023-06-28
K223495Zeolite Hemostatic CottonHangzhou Zeo-Innov Life Technology Co., Ltd.2023-05-02
K222909Axiostat GauzeAdvamedica, Inc.2023-04-07
K210751S.E.A.L. Hemostatic Wound SprayBc3 Technologies, Inc.2023-02-02
K220566Vascette HP (hemostatic pad)Koag, LLC2022-07-29