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

Tube, Single Lumen, With Mercury Wt Balloon For Intestinal Intubation And / Or Decompression

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

FEF is the FDA product code for Tube, Single Lumen, With Mercury Wt Balloon For Intestinal Intubation And / Or Decompression, a class II device type, regulated under 21 CFR 876.5980. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
FEF
Device name
Tube, Single Lumen, With Mercury Wt Balloon For Intestinal Intubation And / Or Decompression
Regulation
21 CFR 876.5980
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
1
Ingested recalls
0

Clearances, product code FEF

By decision year
1 clearance under product code FEF with a decision year between 1988 and 1988, 1988 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code FEF by decision year
YearClearances
19881

Applicants with the most clearances

Product code FEF
Applicants holding the most 510(k) clearances under product code FEF
ApplicantClearances
Mizuho Orthopedic Systems Inc1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code FEF.