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

Catheter, Pediatric, General & Plastic Surgery

21 CFR 878.4200 / General, Plastic Surgery
FDA source (opens on fda.gov)

GBN is the FDA product code for Catheter, Pediatric, General & Plastic Surgery, a class I device type, regulated under 21 CFR 878.4200. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
GBN
Device name
Catheter, Pediatric, General & Plastic Surgery
Regulation
21 CFR 878.4200
Device class
Class I
Review panel
General, Plastic Surgery
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
1

Clearances, product code GBN

By decision year
2 clearances under product code GBN with a decision year between 1980 and 1993, 1980 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code GBN by decision year
YearClearances
19801
19931

Applicants with the most clearances

Product code GBN
Applicants holding the most 510(k) clearances under product code GBN
ApplicantClearances
Armm, Inc.1
Hospital Products Intl.1

Companies listing this code with FDA

Companies whose registered establishments list this code