Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

TRAUMAGEL® 2.0 Hemostatic Gel

K-Number: K253609 · 2025-12-12

ApplicantCresilon, Inc.
Decision Date2025-12-12
Product CodeQSY
DecisionSubstantially Equivalent

Device Summary

TRAUMAGEL® 2.0 Hemostatic Gel is the device name listed in this FDA 510(k) record. The listed applicant is Cresilon, Inc.. It received FDA 510(k) clearance on 2025-12-12 under 510(k) number K253609. The device is classified under product code QSY. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRAUMAGEL® 2.0 Hemostatic Gel?

TRAUMAGEL® 2.0 Hemostatic Gel is a medical device that received FDA 510(k) clearance on 2025-12-12. The listed applicant is Cresilon, Inc.. The 510(k) number is K253609.

When did TRAUMAGEL® 2.0 Hemostatic Gel receive FDA 510(k) clearance?

TRAUMAGEL® 2.0 Hemostatic Gel received FDA 510(k) clearance on 2025-12-12, under 510(k) number K253609.

Who is the listed applicant for TRAUMAGEL® 2.0 Hemostatic Gel?

The FDA 510(k) record lists Cresilon, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRAUMAGEL® 2.0 Hemostatic Gel?

The FDA product code for TRAUMAGEL® 2.0 Hemostatic Gel is QSY.

Other records listing Cresilon, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K240713TRAUMAGEL®K213652Cresilon Hemostatic Gel, CHG, Cresilon Hemostatic Gel (CHG)

Related Devices (Code: QSY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253017BloodSTOP iX Trauma Matrix (TM-iX-20)Lifescience Plus, Inc.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 LimitedK250319MFUSE (MS001)Machina Medical, Inc.K240713TRAUMAGEL®Cresilon, Inc.K240097Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5)Ushare Medical, Inc.K232216Hemoblock_S (Prescription); Hemoblock_S (OTC)Incore Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑