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)

HEMCON HEMOSTATIC GEL

K-Number: K112215 · 2012-04-12

ApplicantHemcon Medical Technologies Europe, Ltd.
Decision Date2012-04-12
Product CodeQSY
DecisionSubstantially Equivalent

Device Summary

HEMCON HEMOSTATIC GEL is the device name listed in this FDA 510(k) record. The listed applicant is Hemcon Medical Technologies Europe, Ltd.. It received FDA 510(k) clearance on 2012-04-12 under 510(k) number K112215. The device is classified under product code QSY. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMCON HEMOSTATIC GEL?

HEMCON HEMOSTATIC GEL is a medical device that received FDA 510(k) clearance on 2012-04-12. The listed applicant is Hemcon Medical Technologies Europe, Ltd.. The 510(k) number is K112215.

When did HEMCON HEMOSTATIC GEL receive FDA 510(k) clearance?

HEMCON HEMOSTATIC GEL received FDA 510(k) clearance on 2012-04-12, under 510(k) number K112215.

Who is the listed applicant for HEMCON HEMOSTATIC GEL?

The FDA 510(k) record lists Hemcon Medical Technologies Europe, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEMCON HEMOSTATIC GEL?

The FDA product code for HEMCON HEMOSTATIC GEL is QSY.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Hemcon Medical Technologies Europe, Ltd. 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.

K121485GUARDIVA ANTIMICROBIAL HAEMSTATIC IV DRESSINGK093729GUARDIVA ANTIMICROBIAL HAEMOSTATIC IV DRESSING, 1 IN/ 4MM, STERILE, GUARD IVA ANTIMICROBIAL HAEMOSTATIC IV DRESSING, 1 I

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.K253609TRAUMAGEL® 2.0 Hemostatic GelCresilon, Inc.K240713TRAUMAGEL®Cresilon, Inc.K240097Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5)Ushare Medical, Inc.

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.

↑