510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
QAUClass II

Hemostatic Device For Endoscopic Gastrointestinal Use

21 CFR 878.4456 / General, Plastic Surgery
FDA source (opens on fda.gov)

QAU is the FDA product code for Hemostatic Device For Endoscopic Gastrointestinal Use, a class II device type, regulated under 21 CFR 878.4456. FDA's definition for this code reads: "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". As of , FDA records hold 12 510(k) clearances under this code, the most recent dated , and 7 recalls.

Classification record

Product code
QAU
Device name
Hemostatic Device For Endoscopic Gastrointestinal Use
FDA definition
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.
Regulation
21 CFR 878.4456
Device class
Class II
Review panel
General, Plastic Surgery
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
12
Ingested recalls
8

Clearances, product code QAU

By decision year
12 clearances under product code QAU with a decision year between 2018 and 2026, 2024 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code QAU by decision year
YearClearances
20181
20201
20212
20221
20231
20243
20263

Applicants with the most clearances

Product code QAU
Applicants holding the most 510(k) clearances under product code QAU
ApplicantClearances
3-D Matrix, Inc.3
Wilson-Cook Medical Inc.3
3-D Matrix Europe SAS2
Nextbiomedical Co., Ltd2
Endoclot Plus Co., Ltd.1
Hemostasis, LLC1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 16 companies shown, in name order