Name: FDA 510(k) clearance K120130
Creator: U.S. Food and Drug Administration
Published: 2012-05-21

Clearance details

Applicant: Medigroup, Inc.
Product code: Code FJS
Device class: Class 2
Regulation: 21 CFR 876.5630
Advisory panel: Gastroenterology, Urology
Date received: 2012-01-17
Decision date: 2012-05-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oswego, IL, US

Recent devices under product code FJS

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K180485 — 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 Extender2018-07-27
K130441 — FALLER STYLET2013-04-19
K121383 — PS X SERIES (BASIC COMPONENTS AND CATHETER), PD X SERIES (CATHETER WITH ALL COMPONENTS)2012-09-05
K113354 — VETA PERITONEAL DIALYSIS CATHETER2012-03-13

More clearances from Medigroup, Inc.

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K071167 — FLEX-NECK EXXTENDED PERITONEAL DIALYSIS CATHETER AND ACCESSORIES, MODEL CF-55602007-08-31
K070730 — FLEX-NECK ARC CATHETER2007-07-03
K060897 — EMBEDDING TOOL, MODEL TE-10002006-07-18
K031351 — FLEX-NECK PD CATHETER, INFANT2003-09-17
K974570 — PERITONEAL DIALYSIS CATHETER CONNECTOR1998-02-27

Adverse events under product code FJS

product code FJS

Death: 34
Injury: 652
Malfunction: 576
Other: 6
Total: 1,268

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →