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510(k) Data Aggregation
K Number
K240713Device Name
TRAUMAGEL®
Manufacturer
Cresilon, Inc.
Date Cleared
2024-08-14
(152 days)
Product Code
QSY
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Cresilon, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
TRAUMAGEL® is a hemostatic gel indicated for temporary external use for controlling moderate to severe bleeding.
Device Description
TRAUMAGEL® is a single-use, hemostatic gel indicated for temporary external use only. The subject device is supplied as an individually pouched 30 mL hemostatic gel syringe, containing chitosan [poly (N-acetyl-D-glucosamine, D-glucosamine)] granules suspended in a sodium alginate hydrogel and is enclosed in a protective pouch. Each syringe is terminally sterilized with gamma irradiation to a sterility assurance level (SAL) of 10th. The hemostatic gel is viscous, opaque and tan in color.
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K Number
K213652Device Name
Cresilon Hemostatic Gel, CHG, Cresilon Hemostatic Gel (CHG)
Manufacturer
Cresilon, Inc.
Date Cleared
2023-06-28
(586 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Cresilon, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Cresilon Hemostatic Gel™ (CHG™) is a hemostatic gel for external use only.
Cresilon Hemostatic Gel™ (CHG™) is indicated for the local management of bleeding wounds such as minor cuts, minor lacerations, and minor abrasions.
Device Description
Cresilon Hemostatic Gel™ (CHG™) is a hemostatic gel for external use only, indicated for the local management of bleeding wounds such as minor cuts, minor lacerations, and minor abrasions.
CHG's hemostatic gel is comprised of poly(N-acetyl-D-glucosamine, D-glucosamine), sodium alginate, and water. CHG is supplied as individually pouched, sterile, pre-filled, single-use syringes. Each syringe is a single 5 mL hemostatic gel application. CHG is packaged in a box containing two (2) CHG applications.
After removal from the pouch, the cap is unscrewed, and the syringe is primed, the hemostatic gel is topically applied directly to the source of bleeding via the syringe.
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