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

Pancreatic Stent, Covered, Metallic, Removable

21 CFR 876.5015 / Gastroenterology, Urology
FDA source (opens on fda.gov)

PCU is the FDA product code for Pancreatic Stent, Covered, Metallic, Removable, a class II device type, regulated under 21 CFR 876.5015. FDA's definition for this code reads: "To facilitate transmural endoscopic drainage of pancreatic pseudocysts". As of , FDA records hold 11 510(k) clearances under this code, the most recent dated , and 6 recalls.

Classification record

Product code
PCU
Device name
Pancreatic Stent, Covered, Metallic, Removable
FDA definition
To facilitate transmural endoscopic drainage of pancreatic pseudocysts
Regulation
21 CFR 876.5015
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
11
Ingested recalls
6

Clearances, product code PCU

By decision year
11 clearances under product code PCU with a decision year between 2013 and 2026, 2015 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code PCU by decision year
YearClearances
20131
20141
20153
20171
20192
20211
20221
20261

Applicants with the most clearances

Product code PCU
Applicants holding the most 510(k) clearances under product code PCU
ApplicantClearances
Boston Scientific Corporation8
Xlumena, Inc.2
Taewoong Medical Co., Ltd.1

Companies listing this code with FDA

Companies whose registered establishments list this code