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Male, Nelaton-tip Ready-to-Use Hydrophilic Catheter +4 more models

FDA 510(k)

Class II (US FDA 510(k))

510(k) K192468

by Hangzhou Bever Medical Devices Co., Ltd.

Identifiers

510(k) Number
K192468 FDA 510(k)
FDA Product Code
GBM FDA 510(k)
Models / Variants
Male, Nelaton-tip Ready-to-Use Hydrophilic Catheter FDA 510(k)
Femal, Nelaton-tip Ready-to-Use Hydrophilic Catheter FDA 510(k)
Pediatric, Nelaton-tip Ready-to-Use Hydrophilic Catheter Intermittent Catheter FDA 510(k)
Male, Tapered-Tip Tiemann Ready-to-Use Hydrophilic Catheter FDA 510(k)
Male, Olive-Tip Tiemann Ready-to-Use Hydrophilic Catheter 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)

Male, Nelaton-tip Ready-to-Use Hydrophilic Catheter +4 more models by Hangzhou Bever Medical Devices Co., Ltd. — Class II — FDA_510K — listed in FDA 510(k)…

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Hangzhou Bever Medical Devices Co., Ltd.

Sources (1)

  • FDA 510(k) K192468 24 fields · synced Jun 18, 2026