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ALL SILICONE HEMATURIA CATHETER - 4864

FDA 510(k)

Class II (US FDA 510(k))

510(k) K021142

by Fortune Medical Instrument Corp.

Identifiers

510(k) Number
K021142 FDA 510(k)
FDA Product Code
EZL FDA 510(k)
Models / Variants
4861 FDA 510(k)
4862 FDA 510(k)
4863 FDA 510(k)
4864 FDA 510(k)
4865 FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.5130 FDA 510(k)
Regulation Number
876.5130 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

ALL SILICONE HEMATURIA CATHETER - 4864 by Fortune Medical Instrument Corp. — Class II — FDA_510K — listed in FDA 510(k) — 5 models

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Fortune Medical Instrument Corp.

Sources (1)

  • FDA 510(k) K021142 24 fields · synced Jun 18, 2026