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

Gastrointestional Tube Holder

21 CFR 876.5980 / Gastroenterology, Urology
FDA source (opens on fda.gov)

PLI is the FDA product code for Gastrointestional Tube Holder, a class II device type, regulated under 21 CFR 876.5980. FDA's definition for this code reads: "Intended to support, secure, and hold gastrointestinal tubes". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
PLI
Device name
Gastrointestional Tube Holder
FDA definition
Intended to support, secure, and hold gastrointestinal tubes
Regulation
21 CFR 876.5980
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code PLI

By decision year
1 clearance under product code PLI with a decision year between 1996 and 1996, 1996 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PLI by decision year
YearClearances
19961

Applicants with the most clearances

Product code PLI
Applicants holding the most 510(k) clearances under product code PLI
ApplicantClearances
Dale Medical Products, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code