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

Catheter, Urological (Antimicrobial) And Accessories

21 CFR 876.5130 / Gastroenterology, Urology
FDA source (opens on fda.gov)

MJC is the FDA product code for Catheter, Urological (Antimicrobial) And Accessories, a class II device type, regulated under 21 CFR 876.5130. As of , FDA records hold 10 510(k) clearances under this code, the most recent dated , and 23 recalls.

Classification record

Product code
MJC
Device name
Catheter, Urological (Antimicrobial) And Accessories
Regulation
21 CFR 876.5130
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
10
Ingested recalls
23

Clearances, product code MJC

By decision year
10 clearances under product code MJC with a decision year between 1994 and 2024, 1998 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code MJC by decision year
YearClearances
19941
19982
19992
20002
20042
20241

Applicants with the most clearances

Product code MJC
Applicants holding the most 510(k) clearances under product code MJC
ApplicantClearances
C.R. Bard Inc4
Rochester Medical Corp.3
Bard Medical Div.1
Cook Incorporated1
Well Lead Medical (Hainan) Co., Ltd.1

Companies listing this code with FDA

Companies whose registered establishments list this code