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All Silicone Suprapubic Catheter, Models 4880/4890

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K014002

by Fortune Medical Instrument Corp.

Identifiers

510(k) Number
K014002 FDA 510(k)
FDA Product Code
KOB FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.5090 FDA 510(k)
Regulation Number
876.5090 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The All Silicone Suprapubic Catheter, Models 4880/4890, is a medical device classified as a Catheter, Suprapubic (and Accessories). It is designed for urinary drainage via a suprapubic route, providing a non-invasive alternative for patients requiring long-term catheterisation. Constructed entirely from silicone, it offers flexibility and biocompatibility to reduce irritation and infection risk.

This device is supplied sterile and intended for single-use, though reuse may occur under controlled clinical conditions. It is regulated under the Medical Device Directive (MDD) and holds FDA 510(k) clearance as substantially equivalent to a predicate device. Models 4880 and 4890 are available in sterile packaging, with storage requirements adhering to standard medical device protocols to maintain sterility and functionality.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Fortune Medical Instrument Corp.

Sources (2)

  • FDA 510(k) K014002 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 18, 2026