DeviceClearance

Product code FJS— Gastroenterology, Urology

ANTIMICROBIAL PERITONEAL DIALYSIS COIL CATHETER WITH SPI-ARGENT II

Classification name
Catheter, Peritoneal, Long-Term Indwelling
Device class
Class 2
Regulation
21 CFR 876.5630
Advisory panel
Gastroenterology, Urology
Total cleared
48
First cleared
Most recent

Market context for product code FJS

FDA has cleared 48 devices under product code FJS between 1977 and 2022, filed by 21 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code FJS

Adverse events under product code FJS

product code FJS
Death
34
Injury
652
Malfunction
576
Other
6
Total
1,268

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

Recent clearances under product code FJS

Data sourced from openFDA. This site is unofficial and independent of the FDA.