510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
GBSClass I

Catheter, Ventricular, General & Plastic Surgery

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

GBS is the FDA product code for Catheter, Ventricular, General & Plastic Surgery, a class I device type, regulated under 21 CFR 878.4200. As of , FDA records hold 27 510(k) clearances under this code, the most recent dated , and 20 recalls.

Classification record

Product code
GBS
Device name
Catheter, Ventricular, 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
27
Ingested recalls
20

Clearances, product code GBS

By decision year
27 clearances under product code GBS with a decision year between 1980 and 1991, 1986 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code GBS by decision year
YearClearances
19801
19812
19823
19831
19841
19854
19865
19875
19883
19891
19911

Applicants with the most clearances

Product code GBS
Applicants holding the most 510(k) clearances under product code GBS
ApplicantClearances
Axiom Medical, Inc.3
H.W. Andersen Products, Inc.3
C.R. Bard Inc2
Sheridan Catheter Corp.2
Sherwood Medical Co.2
Sil-Med Corp.2
Uresil, LLC2
Atrium Medical Corporation1
Axiom, Inc.1
Genesis Industries, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 33 companies shown, in name order