JMS SAFE WING CATH (SWC)— 510(k) K121488

Clearance details

Applicant

JMS North America Corporation

Product code

Code FOZ

Device class

Class 2

Regulation

21 CFR 880.5200

Advisory panel

General Hospital

Date received

2012-05-18

Decision date

2013-03-05

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Crofton, MD, US

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• K251877 — JMS CAVEO A.V. Fistula Needle Set2025-08-15
• K172499 — NEOSHIELD2018-06-01
• K151017 — JMS Harmony A.V. Fistula Needle Set2015-05-13
• K142564 — JMS SysLoc MINI A.V. Fistula Needle Set (V4), JMS SysLoc MINI Apheresis Needle Set (V4)2014-12-23
• K132321 — JMS SYRINGE2014-02-20

Death

38

Injury

2,290

Malfunction

25,858

Other

11

Total

28,197

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 →