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FDA 510(k)

WOUNDSTAT, MODEL TC1001

K-Number: K071936 · 2007-08-23

ApplicantTraumacure, Inc.
Decision Date2007-08-23
Product CodeQSY
DecisionSubstantially Equivalent

Device Summary

WOUNDSTAT, MODEL TC1001 is the device name listed in this FDA 510(k) record. The listed applicant is Traumacure, Inc.. It received FDA 510(k) clearance on 2007-08-23 under 510(k) number K071936. The device is classified under product code QSY. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WOUNDSTAT, MODEL TC1001?

WOUNDSTAT, MODEL TC1001 is a medical device that received FDA 510(k) clearance on 2007-08-23. The listed applicant is Traumacure, Inc.. The 510(k) number is K071936.

When did WOUNDSTAT, MODEL TC1001 receive FDA 510(k) clearance?

WOUNDSTAT, MODEL TC1001 received FDA 510(k) clearance on 2007-08-23, under 510(k) number K071936.

Who is the listed applicant for WOUNDSTAT, MODEL TC1001?

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

What is the FDA product code for WOUNDSTAT, MODEL TC1001?

The FDA product code for WOUNDSTAT, MODEL TC1001 is QSY.

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Other records listing Traumacure, 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.

K081183WOUNDSTAT

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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