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

Catheter, Irrigation

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

GBX is the FDA product code for Catheter, Irrigation, a class I device type, regulated under 21 CFR 878.4200. As of , FDA records hold 77 510(k) clearances under this code, the most recent dated , and 82 recalls.

Classification record

Product code
GBX
Device name
Catheter, Irrigation
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
77
Ingested recalls
82

Clearances, product code GBX

By decision year
77 clearances under product code GBX with a decision year between 1977 and 2014, 1994 the highest year at 12.
Show the numbers
510(k) clearances under FDA product code GBX by decision year
YearClearances
19773
19781
19822
19831
19844
19856
19871
19881
19894
19901
19914
19926
19939
199412
19956
19966
19973
19981
20001
20021
20052
20081
20141

Applicants with the most clearances

Product code GBX
Applicants holding the most 510(k) clearances under product code GBX
ApplicantClearances
Navarre Biomedical, Ltd.5
Sil-Med Corp.5
Axiom Medical, Inc.3
Kendall Healthcare Products Co. Div.Of Tyco Health3
Mikro-Tek Laboratories3
Boston Scientific Corporation3
Baxter Healthcare Corporation2
Becton Dickinson Vascular Access, Inc.2
Intl. Medical Devices, Ltd.2
Regulatory & Marketing Services, Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 200 companies shown, in name order