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
QIJClass II

Endoscopic Transhepatic Venous Access Needle

21 CFR 876.1050 / Gastroenterology, Urology
FDA source (opens on fda.gov)

QIJ is the FDA product code for Endoscopic Transhepatic Venous Access Needle, a class II device type, regulated under 21 CFR 876.1050. FDA's definition for this code reads: "An endoscopic transhepatic venous access needle is inserted through the liver into the patient’s portal/hepatic venous system under endoscopic ultrasound guidance. It is connected to a separate device intended to measure a physiological parameter". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
QIJ
Device name
Endoscopic Transhepatic Venous Access Needle
FDA definition
An endoscopic transhepatic venous access needle is inserted through the liver into the patient’s portal/hepatic venous system under endoscopic ultrasound guidance. It is connected to a separate device intended to measure a physiological parameter.
Regulation
21 CFR 876.1050
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code QIJ

By decision year
1 clearance under product code QIJ with a decision year between 2019 and 2019, 2019 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QIJ by decision year
YearClearances
20191

Applicants with the most clearances

Product code QIJ
Applicants holding the most 510(k) clearances under product code QIJ
ApplicantClearances
Cook Ireland Ltd.1

Companies listing this code with FDA

Companies whose registered establishments list this code