What is FDA product code QAU?

Hemostatic device for intraluminal gastrointestinal use. A hemostatic device for intraluminal gastrointestinal use is a prescription device that is endoscopically applied to the upper and/or lower gastrointestinal tract and is intended to produce hemostasis via absorption of fluid or by other physical means.

General & Plastic Surgery › SurgicalHemostatic Device For Endoscopic Gastrointestinal Use

EndoClot

Name: EndoClot
Brand: EndoClot

EndoClot®Polysaccharide Hemostatic System, EndoClot® PHS

Registry build 21.09.26

1manufacturer

1catalogue number

1510(k) clearance

Who Else Makes It

Registered in Jiangsu.

Chinese manufacturers registered for FDA product code QAU
Manufacturer	City	Province	Registered as	Device types
Endoclot Plus Co., Ltd.	Suzhou	Jiangsu	Manufacturer	5

Record

Regulatory record for EndoClot
Listed by	Endoclot Plus Co., Ltd., China
FDA product code	QAU
Device type	Hemostatic Device For Endoscopic Gastrointestinal Use
Device class	Class 2
Regulation	21 CFR 878.4456
Establishment	Manufacturer
510(k)	K190677
Record published	2022-03-15

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Supplied as a kit	Yes
Label carries	lot or batch number, expiry date, manufacturing date
Packaging	Pack of 14

Catalogue Numbers

Catalogue numbers for EndoClot
Catalogue number	Size	Status
EPK2302-01		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Nexpowder	Nextbiomedical Co., Ltd.	3
PuraStat	3-D Matrix Europe SAS	2
Hemospray	Cook Incorporated	2
PuraStat (3mL)	3-D Matrix, Ltd.	1
PuraStat (1mL)	3-D Matrix, Ltd.	1

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K190677	2021-01-29

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.