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

Nexpowder

Name: Nexpowder
Brand: Nexpowder

Nexpowder is used for hemostasis of nonvariceal gastrointestinal bleeding.

Registry build 21.09.26

1manufacturer

3catalogue numbers in this listing

2510(k) clearances naming this product code

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 Nexpowder
Listed by	Nextbiomedical Co., Ltd., South Korea
FDA product code	QAU
Device type	Hemostatic Device For Endoscopic Gastrointestinal Use
Device class	Class 2
Regulation	21 CFR 878.4456
Establishment	Complaint-file establishment, Manufacturer
Record published	2022-09-27
Record revised	2025-05-20 (version 4)

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	expiry date, serial number
Storage	Storage environment temperature 0 to 40 °C
Packaging	Box of 5, box of 90, 90 of 5

Catalogue Numbers

Catalogue numbers for Nexpowder
Catalogue number	Size	Status
NHS03		In distribution
NHS02		In distribution
NHS01		In distribution

Same Product Code

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

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K240994	2024-11-27
K202929	2022-09-16

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.