PFENot classified

Gastrointestinal Liner System

Unknown

PFE is the FDA product code for Gastrointestinal Liner System. FDA's definition for this code reads: "for the treatment of type 2 diabetes. The gastrointestinal liner is indicated for a maximum of 12 months". As of 2026-09-10, FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code: PFE
Device name: Gastrointestinal Liner System
FDA definition: for the treatment of type 2 diabetes. The gastrointestinal liner is indicated for a maximum of 12 months.
Device class: Not classified
Review panel: Unknown
Submission type: Contact ODE
Implant: Yes
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 0
Ingested recalls: 0

Companies listing this code with FDA

Companies whose registered establishments list this code

Recent clearances

Product code PFE

FDA records hold no clearances under product code PFE.

Recent recalls

Product code PFE

FDA records show no recalls under product code PFE.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)