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FDA 510(k)

POSISEP AND POSISEP X HEMOSTAT DRESSINGS

K-Number: K120958 · 2012-07-25

ApplicantHemostasis, LLC
Decision Date2012-07-25
Product CodeQSY
DecisionSubstantially Equivalent

Device Summary

POSISEP AND POSISEP X HEMOSTAT DRESSINGS is the device name listed in this FDA 510(k) record. The listed applicant is Hemostasis, LLC. It received FDA 510(k) clearance on 2012-07-25 under 510(k) number K120958. The device is classified under product code QSY. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POSISEP AND POSISEP X HEMOSTAT DRESSINGS?

POSISEP AND POSISEP X HEMOSTAT DRESSINGS is a medical device that received FDA 510(k) clearance on 2012-07-25. The listed applicant is Hemostasis, LLC. The 510(k) number is K120958.

When did POSISEP AND POSISEP X HEMOSTAT DRESSINGS receive FDA 510(k) clearance?

POSISEP AND POSISEP X HEMOSTAT DRESSINGS received FDA 510(k) clearance on 2012-07-25, under 510(k) number K120958.

Who is the listed applicant for POSISEP AND POSISEP X HEMOSTAT DRESSINGS?

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 POSISEP AND POSISEP X HEMOSTAT DRESSINGS?

The FDA product code for POSISEP AND POSISEP X HEMOSTAT DRESSINGS 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 SPLINTK122886NEXSTAT PLUS AND NEXFOAM PLUS TOPICAL HEMOSTAT DRESSINGK102459NEXSTAT (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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