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FDA 510(k)

NasalCEASE and BleedCEASE

K-Number: K183622 · 2019-12-02

ApplicantLes Laboratoires Brothier S.A.
Decision Date2019-12-02
Product CodeQSY
DecisionSubstantially Equivalent

Device Summary

NasalCEASE and BleedCEASE is the device name listed in this FDA 510(k) record. The listed applicant is Les Laboratoires Brothier S.A.. It received FDA 510(k) clearance on 2019-12-02 under 510(k) number K183622. The device is classified under product code QSY. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NasalCEASE and BleedCEASE?

NasalCEASE and BleedCEASE is a medical device that received FDA 510(k) clearance on 2019-12-02. The listed applicant is Les Laboratoires Brothier S.A.. The 510(k) number is K183622.

When did NasalCEASE and BleedCEASE receive FDA 510(k) clearance?

NasalCEASE and BleedCEASE received FDA 510(k) clearance on 2019-12-02, under 510(k) number K183622.

Who is the listed applicant for NasalCEASE and BleedCEASE?

The FDA 510(k) record lists Les Laboratoires Brothier S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NasalCEASE and BleedCEASE?

The FDA product code for NasalCEASE and BleedCEASE is QSY.

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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