Traumagel®

FDA 510(k) K240713 · Cresilon, Inc.

Substantially Equivalent

510(k) numberK240713

Submission

Device name
Traumagel®
Applicant
Cresilon, Inc.
Brooklyn, NY, US
Received
March 15, 2024
Decision date
August 14, 2024
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
QSY – Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Device class
Unclassified

To temporarily control bleeding and cover external wounds.

Other 510(k)s with product code QSY

510(k)DeviceApplicantDecision
K253017BloodSTOP iX Trauma Matrix (TM-iX-20)QSY · Traditional Lifescience Plus, Inc.04/30/2026SE
K251700Ganymede 2cm diameter (FG100300); Ganymede 5cm x 5cm (FG100400); Ganymede 10cm x 10cm…QSY · Traditional Speciality Fibres and Materials Limited02/26/2026SE
K250319Mfuse (MS001)QSY · Traditional Machina Medical, Inc.12/15/2025SE
K253609TRAUMAGEL® 2.0 Hemostatic GelQSY · Special Cresilon, Inc.12/12/2025SE
K240097Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5)QSY · Traditional Ushare Medical, Inc.05/22/2024SE
K232216Hemoblock_S (Prescription); Hemoblock_S (OTC)QSY · Traditional Incore Co., Ltd.04/19/2024SE
K240454RESPONDER® Polysaccharide HemostatQSY · Special Starch Medical, Inc.03/15/2024SE
K220525RESPONDER Polysaccharide HemostatQSY · Traditional Starch Medical, Inc.12/04/2023SE
K230589Celox Rapid X-Ray GauzeQSY · Traditional Medtrade Products , Ltd.11/17/2023SE
K213413Hemostatic DressingQSY · Traditional Jiangsu Newvalue Medical Products Co., Ltd.09/01/2023SE

More from Jiangsu Newvalue Medical Products Co., Ltd.

510(k)DeviceDecision
K253609TRAUMAGEL® 2.0 Hemostatic GelQSY · Special 12/12/2025SE
K213652Cresilon Hemostatic Gel, CHG, Cresilon Hemostatic Gel (CHG)QSY · Traditional 06/28/2023SE

Questions and answers

When was Traumagel® cleared by the FDA?

Traumagel® (K240713) received a 510(k) decision of Substantially Equivalent on August 14, 2024, 152 days after the submission was received.

What is the product code of K240713?

The FDA product code is QSY – Hemostatic Wound Dressing Without Thrombin Or Other Biologics, a Unclassified device.