← FDA Medical Device Classifications

Gastrointestinal Liner System

PFE · Not classified · Unknown

Classification

FDA Product Code
PFE
Device class
Not classified
Regulation
Review panel
GU
Medical specialty
Unknown
Submission type
3
GMP exempt
N
Life sustaining
N
Implant
Y
Third-party review
N

Definition

for the treatment of type 2 diabetes. The gastrointestinal liner is indicated for a maximum of 12 months.

Market data

Cleared 510(k) submissions
0
Registered establishments
2

Source

Authoritative
FDA Device Classification database
Machine
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