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RenaFlex Single-use Flexible Ureteroscope (SUURF-V Standard) +2 more models

FDA 510(k)

Class II (US FDA 510(k))

510(k) K233275

by Gyrus Acmi, Inc.

Identifiers

510(k) Number
K233275 FDA 510(k)
FDA Product Code
FGB FDA 510(k)
Models / Variants
RenaFlex Single-use Flexible Ureteroscope (SUURF-V Standard) FDA 510(k)
RenaFlex Single-use Flexible Ureteroscope (SUURF-VR Reverse) FDA 510(k)
Video System Center for Single-use Endoscopes (CV-S1) FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.1500 FDA 510(k)
Regulation Number
876.1500 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

RenaFlex Single-use Flexible Ureteroscope (SUURF-V Standard) +2 more models by Gyrus Acmi, Inc. — Class II — FDA_510K — listed in FDA 510(k) — 3 models

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Gyrus Acmi, Inc.

Sources (1)

  • FDA 510(k) K233275 24 fields · synced Jun 18, 2026