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

Catheter, Peritoneal

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

GBW is the FDA product code for Catheter, Peritoneal, a class I device type, regulated under 21 CFR 878.4200. As of , FDA records hold 17 510(k) clearances under this code, the most recent dated , and 15 recalls.

Classification record

Product code
GBW
Device name
Catheter, Peritoneal
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
17
Ingested recalls
15

Clearances, product code GBW

By decision year
17 clearances under product code GBW with a decision year between 1980 and 1999, 1981 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code GBW by decision year
YearClearances
19801
19813
19841
19861
19892
19911
19931
19941
19963
19971
19992

Applicants with the most clearances

Product code GBW
Applicants holding the most 510(k) clearances under product code GBW
ApplicantClearances
Sil-Med Corp.4
Taut, Inc.3
A.D.T. Lab Industries1
Arrow Intl., Inc.1
Core Dynamics, Inc.1
Freudenberg Medical, LLC1
Madegom1
Medi-Tech, Inc.1
Medical Components, Inc.1
Research Medical, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 46 companies shown, in name order