Data / Medical devices / Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)

Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) (FCM): 28 FDA-registered makers in 8 countries

28 establishments in 8 countries are registered with the FDA to make Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) (product code FCM, Class 2, 21 CFR 876.5130). 14 of them have a 510(k) clearance or PMA approval on file and 3 have a recall event. The FDA has issued 60 510(k) clearances under this code, the latest on May 29, 2026, and lists 10 recall events (1 Class I). FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Product code

FCM

Device class

2

Regulation

876.5130

Medical specialty

Gastroenterology, Urology

Makers by country

Makers of Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

Updated May 29, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.