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

Catheter, Continuous Irrigation

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

GBQ is the FDA product code for Catheter, Continuous Irrigation, a class I device type, regulated under 21 CFR 878.4200. As of , FDA records hold 8 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
GBQ
Device name
Catheter, Continuous 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
8
Ingested recalls
1

Clearances, product code GBQ

By decision year
8 clearances under product code GBQ with a decision year between 1977 and 1994, 1987 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code GBQ by decision year
YearClearances
19771
19791
19873
19881
19921
19941

Applicants with the most clearances

Product code GBQ
Applicants holding the most 510(k) clearances under product code GBQ
ApplicantClearances
Acumed Instruments Corp.1
Concept, Inc.1
Gesco Intl., Inc.1
Ipax, Inc.1
JEDMED Instrument Company1
Quinton, Inc.1
Specialty Medical Products Co.1
Trinity Laboratories, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 22 companies shown, in name order