510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QNEClass II

Endoscopic Pancreatic Debridement Device

21 CFR 876.4330 / Gastroenterology, Urology
FDA source (opens on fda.gov)

QNE is the FDA product code for Endoscopic Pancreatic Debridement Device, a class II device type, regulated under 21 CFR 876.4330. FDA's definition for this code reads: "An endoscopic pancreatic debridement device is inserted via an endoscope and placed through a cystogastrostomy fistula into the pancreatic cavity. It is intended for removal of necrotic tissue from a walled off pancreatic necrosis (WOPN) cavity". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
QNE
Device name
Endoscopic Pancreatic Debridement Device
FDA definition
An endoscopic pancreatic debridement device is inserted via an endoscope and placed through a cystogastrostomy fistula into the pancreatic cavity. It is intended for removal of necrotic tissue from a walled off pancreatic necrosis (WOPN) cavity.
Regulation
21 CFR 876.4330
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 QNE

By decision year
1 clearance under product code QNE with a decision year between 2020 and 2020, 2020 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QNE by decision year
YearClearances
20201

Applicants with the most clearances

Product code QNE
Applicants holding the most 510(k) clearances under product code QNE
ApplicantClearances
Interscope, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code