FJS · Class II · 21 CFR 876.5630

FDA Product Code FJS: Catheter, Peritoneal, Long-term Indwelling

Leading manufacturers include Quinton, Inc., Accurate Surgical Instruments Co. and Medigroup, Inc..

48
Total
48
Cleared
139d
Avg days
1977
Since
Stable submission activity - 0 submissions in the last 2 years

FDA 510(k) Cleared Catheter, Peritoneal, Long-term Indwelling Devices (Product Code FJS)

48 devices
1–24 of 48
Cleared Jan 14, 2022
Argyle Peritoneal Dialysis Cathetor and Kit, Ritus Peritoneal Dialysis Catheter Tunneling Tool Kit
K213602
Covidien, LLC
Gastroenterology & Urology · 60d
Cleared Jul 27, 2018
Argyle Peritoneal Dialysis Catheter and Kits, Argyle Presternal Peritoneal Dialysis Catheter and Kits, Argyle Peritoneal Dialysis Accessory Two Part Titanium Luer Adapter, Argyle Adult Peritoneal Dialysis Accessory Titanium Catheter Extender
K180485
Covidien, LLC
Gastroenterology & Urology · 154d
Cleared Apr 19, 2013
FALLER STYLET
K130441
Medionics International, Inc.
Gastroenterology & Urology · 57d
Cleared Sep 05, 2012
PS X SERIES (BASIC COMPONENTS AND CATHETER), PD X SERIES (CATHETER WITH ALL COMPONENTS)
K121383
Medical Components, Inc.
Gastroenterology & Urology · 120d
Cleared May 21, 2012
FALLER TROCAR
K120130
Medigroup, Inc.
Gastroenterology & Urology · 125d
Cleared Mar 13, 2012
VETA PERITONEAL DIALYSIS CATHETER
K113354
Pfm Medical, Inc.
Gastroenterology & Urology · 120d
Cleared Aug 31, 2007
FLEX-NECK EXXTENDED PERITONEAL DIALYSIS CATHETER AND ACCESSORIES, MODEL CF-5560
K071167
Medigroup, Inc.
Gastroenterology & Urology · 127d
Cleared Jul 03, 2007
FLEX-NECK ARC CATHETER
K070730
Medigroup, Inc.
Gastroenterology & Urology · 110d
Cleared Jul 18, 2006
EMBEDDING TOOL, MODEL TE-1000
K060897
Medigroup, Inc.
Gastroenterology & Urology · 106d
Cleared Mar 29, 2006
PD CATH
K053123
Med-Conduit, Inc.
Gastroenterology & Urology · 142d
Cleared Sep 17, 2003
FLEX-NECK PD CATHETER, INFANT
K031351
Medigroup, Inc.
Gastroenterology & Urology · 141d
Cleared Feb 04, 2002
MEDIGROUP CATHETER EXTENDER/REPAIR KIT
K012502
Janin Group, Inc.
Gastroenterology & Urology · 185d
Cleared Dec 06, 2001
MEDIGROUP KEY TUBE
K013017
Janin Group, Inc.
Gastroenterology & Urology · 90d
Cleared Apr 28, 2000
PERITONEAL DIALYSIS CATHETERS AND ADAPTERS
K993149
Medionics International, Inc.
Gastroenterology & Urology · 220d
Cleared Jun 25, 1999
ASH ADVANTAGE PERITONEAL CATHETER
K991042
Janin Group, Inc.
Gastroenterology & Urology · 88d
Cleared Sep 05, 1997
FLEX-NECK PD CATHETER
K970159
Janin Group, Inc.
Gastroenterology & Urology · 232d
Cleared Jul 18, 1997
ANTIMICROBIAL PERITONEAL DIALYSIS COIL CATHETER WITH SPI-ARGENT II
K961392
Sil-Med Corp.
Gastroenterology & Urology · 463d
Cleared Dec 15, 1995
SWAN NECK PRESTERNAL PERITONEAL DIALYSIS CATHETER
K950042
Accurate Surgical Instruments Co.
Gastroenterology & Urology · 344d
Cleared Sep 23, 1994
CATH DOME PD- WATER RESISTANT COVER FOR INDWELLING PERITONEAL DIALYSIS CATHETERS AND TRANSFER SETS
K934610
Tabex Industries, Inc.
Gastroenterology & Urology · 361d
Cleared Jun 23, 1994
CATH BELT PD CATHETER AND TRANSFER SET HOLDER
K930175
Tabex Industries, Inc.
Gastroenterology & Urology · 526d
Cleared Feb 02, 1994
MEDCOMP PERITONEAL DIALYSIS CATHETERS
K915490
Medical Components, Inc.
Gastroenterology & Urology · 789d
Cleared May 04, 1992
INSERTION
K920515
Accurate Surgical Instruments Co.
Gastroenterology & Urology · 90d
Cleared Sep 19, 1991
TROCAR (FALLER STYLET)
K910786
Accurate Surgical Instruments Co.
Gastroenterology & Urology · 206d
Cleared Aug 22, 1991
TITANIUM CATHETER EXTENDER
K910785
Accurate Surgical Instruments Co.
Gastroenterology & Urology · 178d

About Product Code FJS - Regulatory Context

510(k) Submission Activity

48 total 510(k) submissions under product code FJS since 1977, with 48 receiving FDA clearance (average review time: 139 days).

Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.