Data / Medical devices / United States / Hemostasis, LLC

Hemostasis, LLC: FDA-registered device maker in Saint Paul, MN, United States, 6 510(k) clearances

Name: Hemostasis, LLC FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Hemostasis, LLC is registered with the FDA (registration 3007225047) in Saint Paul, MN, United States. It lists 7 device types. The FDA files 6 510(k) clearances under its listings, the newest dated July 26, 2024. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3007225047
Address: 5000 Township Pkwy, Saint Paul, MN, United States, 55110
Owner or operator: Hemostasis, LLC (10023101)
Roles: Manufacturer
First device listed: December 13, 2010
Registered through: 2027
Brand names listed: BleedArrest ER Topical Hemostat, GI House CO2 Flow Controller, GI Tank CO2 Flow Controller, NexFoam Plus Topical Hemostat Sponge, NexFoam Topical Hemostat Sponge, NexPak Intranasal Splint, NexPak X Intranasal Splint, NexPak XL Intranasal Splint and more

Devices it lists

Device	Product code	Class	Role	Source
Balloon, Epistaxis	EMX	1	Manufacturer	accessdata.fda.gov
Hemostatic Device For Endoscopic Gastrointestinal Use	QAU	2	Manufacturer	accessdata.fda.gov
Hemostatic Wound Dressing Without Thrombin Or Other Biologics	QSY	U	Manufacturer	accessdata.fda.gov
Nasal Spray, Ent Delivery	KCO	1	Manufacturer	accessdata.fda.gov
Polymer, Ear, Nose And Throat, Synthetic, Absorbable	NHB	2	Manufacturer	accessdata.fda.gov
Splint, Intranasal Septal	LYA	1	Manufacturer	accessdata.fda.gov
Tube, Thorpe, Uncompensated	BYM	1	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
July 26, 2024	K234131	Resolv Endoscopic Hemostat System	QAU	Substantially Equivalent	Hemostasis, LLC	accessdata.fda.gov
November 14, 2022	K220326	PosiSep X BAM Hemostat Dressing/Intranasal Splint	EMX	Substantially Equivalent	Hemostasis, LLC	accessdata.fda.gov
March 27, 2013	K122494	POSISEP AND POSISEP X HEMOSTAT DRESSING/INTRANASAL SPLINT	LYA	Substantially Equivalent	Hemostasis, LLC	accessdata.fda.gov
November 15, 2012	K122886	NEXSTAT PLUS AND NEXFOAM PLUS TOPICAL HEMOSTAT DRESSING	QSY	Substantially Equivalent	Hemostasis, LLC	accessdata.fda.gov
July 25, 2012	K120958	POSISEP AND POSISEP X HEMOSTAT DRESSINGS	QSY	Substantially Equivalent	Hemostasis, LLC	accessdata.fda.gov
December 3, 2010	K102459	NEXSTAT (TM) TOPICAL HEMOSTAT POWDER; NEXFOAM (R) TOPICAL SPONGE	QSY	Substantially Equivalent	Hemostasis, LLC	accessdata.fda.gov

Compare with other makers

Updated July 26, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.