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FDA 510(k)

SORBASTACE

K-Number: K965034 · 1998-04-09

ApplicantHemostace, LLC
Decision Date1998-04-09
Product CodeQSY
DecisionSubstantially Equivalent for Some Indications

Device Summary

SORBASTACE is the device name listed in this FDA 510(k) record. The listed applicant is Hemostace, LLC. It received FDA 510(k) clearance on 1998-04-09 under 510(k) number K965034. The device is classified under product code QSY. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the SORBASTACE?

SORBASTACE is a medical device that received FDA 510(k) clearance on 1998-04-09. The listed applicant is Hemostace, LLC. The 510(k) number is K965034.

When did SORBASTACE receive FDA 510(k) clearance?

SORBASTACE received FDA 510(k) clearance on 1998-04-09, under 510(k) number K965034.

Who is the listed applicant for SORBASTACE?

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

What is the FDA product code for SORBASTACE?

The FDA product code for SORBASTACE 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

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

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

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