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

Catheter, Peritoneal, Long-Term Indwelling

21 CFR 876.5630 / Gastroenterology, Urology
FDA source (opens on fda.gov)

FJS is the FDA product code for Catheter, Peritoneal, Long-Term Indwelling, a class II device type, regulated under 21 CFR 876.5630. As of , FDA records hold 48 510(k) clearances under this code, the most recent dated , and 8 recalls.

Classification record

Product code
FJS
Device name
Catheter, Peritoneal, Long-Term Indwelling
Regulation
21 CFR 876.5630
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
48
Ingested recalls
8

Clearances, product code FJS

By decision year
48 clearances under product code FJS with a decision year between 1977 and 2022, 1981 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code FJS by decision year
YearClearances
19773
19782
19792
19802
19814
19821
19852
19862
19872
19892
19902
19912
19921
19943
19951
19972
19991
20001
20011
20021
20031
20062
20072
20123
20131
20181
20221

Applicants with the most clearances

Product code FJS
Applicants holding the most 510(k) clearances under product code FJS
ApplicantClearances
Quinton, Inc.8
Accurate Surgical Instruments Co.7
Medigroup5
Janin Group, Inc.4
Sil-Med Corp.3
Medtronic, Inc.2
Dravon Medical, Inc.2
Medical Components, Inc.2
Medionics International, Inc.2
Tabex Industries, Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 22 companies shown, in name order