GCBClass I

Needle, Catheter

21 CFR 878.4200 / General, Plastic Surgery

GCB is the FDA product code for Needle, Catheter, a class I device type, regulated under 21 CFR 878.4200. As of 2026-09-10, FDA records hold 8 510(k) clearances under this code, the most recent dated 2015-11-12, and 8 recalls.

Classification record

Product code: GCB
Device name: Needle, Catheter
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: 8

Clearances, product code GCB

By decision year

8 clearances under product code GCB with a decision year between 1978 and 2015, 1985 the highest year at 2.

Show the numbers

510(k) clearances under FDA product code GCB by decision year
Year	Clearances
1978	1
1985	2
1990	1
1992	1
1993	1
1998	1
2015	1

Applicants with the most clearances

Product code GCB

Applicants holding the most 510(k) clearances under product code GCB
Applicant	Clearances
Medical Dynamics, Inc.	2
Medtronic, Inc.	1
B.Braun Medical, Inc.	1
Concord Laboratories, Inc.	1
Jelco Laboratories	1
Manan Manufacturing Co., Inc.	1
Boston Scientific Corporation	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 57 companies shown, in name order