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FDA 510(k)

NEXSTAT PLUS AND NEXFOAM PLUS TOPICAL HEMOSTAT DRESSING

K-Number: K122886 · 2012-11-15

ApplicantHemostasis, LLC
Decision Date2012-11-15
Product CodeQSY
DecisionSubstantially Equivalent

Device Summary

NEXSTAT PLUS AND NEXFOAM PLUS TOPICAL HEMOSTAT DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Hemostasis, LLC. It received FDA 510(k) clearance on 2012-11-15 under 510(k) number K122886. The device is classified under product code QSY. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEXSTAT PLUS AND NEXFOAM PLUS TOPICAL HEMOSTAT DRESSING?

NEXSTAT PLUS AND NEXFOAM PLUS TOPICAL HEMOSTAT DRESSING is a medical device that received FDA 510(k) clearance on 2012-11-15. The listed applicant is Hemostasis, LLC. The 510(k) number is K122886.

When did NEXSTAT PLUS AND NEXFOAM PLUS TOPICAL HEMOSTAT DRESSING receive FDA 510(k) clearance?

NEXSTAT PLUS AND NEXFOAM PLUS TOPICAL HEMOSTAT DRESSING received FDA 510(k) clearance on 2012-11-15, under 510(k) number K122886.

Who is the listed applicant for NEXSTAT PLUS AND NEXFOAM PLUS TOPICAL HEMOSTAT DRESSING?

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

What is the FDA product code for NEXSTAT PLUS AND NEXFOAM PLUS TOPICAL HEMOSTAT DRESSING?

The FDA product code for NEXSTAT PLUS AND NEXFOAM PLUS TOPICAL HEMOSTAT DRESSING is QSY.

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Other records listing Hemostasis, LLC 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.

K234131Resolv Endoscopic Hemostat SystemK220326PosiSep X BAM Hemostat Dressing/Intranasal SplintK210411PosiSep EAR Fragmentable Ear DressingK122494POSISEP AND POSISEP X HEMOSTAT DRESSING/INTRANASAL SPLINTK120958POSISEP AND POSISEP X HEMOSTAT DRESSINGSK102459NEXSTAT (TM) TOPICAL HEMOSTAT POWDER; NEXFOAM (R) TOPICAL SPONGE

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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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