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

Balloon, Liver Tamponade

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

NGU is the FDA product code for Balloon, Liver Tamponade, 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
NGU
Device name
Balloon, Liver Tamponade
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 NGU

By decision year
1 clearance under product code NGU with a decision year between 2001 and 2001, 2001 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code NGU by decision year
YearClearances
20011

Applicants with the most clearances

Product code NGU
Applicants holding the most 510(k) clearances under product code NGU
ApplicantClearances
Cook Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

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