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

Catheter, Nephrostomy, General & Plastic Surgery

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

GBO is the FDA product code for Catheter, Nephrostomy, General & Plastic Surgery, a class I device type, regulated under 21 CFR 878.4200. As of , FDA records hold 11 510(k) clearances under this code, the most recent dated , and 8 recalls.

Classification record

Product code
GBO
Device name
Catheter, Nephrostomy, 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
11
Ingested recalls
8

Clearances, product code GBO

By decision year
11 clearances under product code GBO with a decision year between 1978 and 2004, 1986 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code GBO by decision year
YearClearances
19781
19791
19821
19865
19911
20021
20041

Applicants with the most clearances

Product code GBO
Applicants holding the most 510(k) clearances under product code GBO
ApplicantClearances
Angiomed U.S., Inc.5
Uresil, LLC3
Dow Corning Corp. Healthcare Industries Materials2
Van-Tec, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 40 companies shown, in name order