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FDA 510(k)

CHITOGAUZE FUSION

K-Number: K111163 · 2011-05-17

ApplicantHem Con Medical Technologies, Inc.
Decision Date2011-05-17
Product CodeQSY
DecisionSubstantially Equivalent

Device Summary

CHITOGAUZE FUSION is the device name listed in this FDA 510(k) record. The listed applicant is Hem Con Medical Technologies, Inc.. It received FDA 510(k) clearance on 2011-05-17 under 510(k) number K111163. The device is classified under product code QSY. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHITOGAUZE FUSION?

CHITOGAUZE FUSION is a medical device that received FDA 510(k) clearance on 2011-05-17. The listed applicant is Hem Con Medical Technologies, Inc.. The 510(k) number is K111163.

When did CHITOGAUZE FUSION receive FDA 510(k) clearance?

CHITOGAUZE FUSION received FDA 510(k) clearance on 2011-05-17, under 510(k) number K111163.

Who is the listed applicant for CHITOGAUZE FUSION?

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

What is the FDA product code for CHITOGAUZE FUSION?

The FDA product code for CHITOGAUZE FUSION is QSY.

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Other records listing Hem Con Medical Technologies, 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.

K153582Prometheus ChitoGauze XR PROK103641GUARDACAREK102546CHITOGAUZEK092357CHITOGAUZE,2 IN X 2 IN,8 PLY, 4 IN X 4 IN 8 PLY, 4 IN X 8 IN, 8PLY, 1 IN X 4 IN, 8PLY, CHITOGAUZE, PACKAGING STRIP, 1/2K090026CHITOGAUZE, MODELS 130, 131, 263, 264, 265, 266K072486MODIFICATION TO HEMCON BANDAGE AND HEMCON BANDAGE OTC

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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.

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