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

Bougie, Esophageal, And Gastrointestinal, Gastro-Urology

21 CFR 876.5365 / Gastroenterology, Urology
FDA source (opens on fda.gov)

FAT is the FDA product code for Bougie, Esophageal, And Gastrointestinal, Gastro-Urology, a class II device type, regulated under 21 CFR 876.5365. As of , FDA records hold 8 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
FAT
Device name
Bougie, Esophageal, And Gastrointestinal, Gastro-Urology
Regulation
21 CFR 876.5365
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
8
Ingested recalls
2

Clearances, product code FAT

By decision year
8 clearances under product code FAT with a decision year between 1978 and 2014, 1978 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code FAT by decision year
YearClearances
19781
19841
19851
19901
19961
19981
19991
20141

Applicants with the most clearances

Product code FAT
Applicants holding the most 510(k) clearances under product code FAT
ApplicantClearances
Dacomed Corp.1
Gabriel Medical, Inc.1
Gaymar Industries, Inc.1
Medovations, Inc.1
Mill-Rose Laboratory1
Stryker Corp.1
Teleflexmedical, Inc.1
TeleMed Systems1

Companies listing this code with FDA

Companies whose registered establishments list this code