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OES Elite Ureteroscopes and Accessories

FDA 510(k)

Class II (US FDA 510(k))

510(k) K200369

by Olympus Winter & Ibe GmbH

Identifiers

510(k) Number
K200369 FDA 510(k)
FDA Product Code
FGB 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)

The OES Elite Ureteroscopes and Accessories are flexible or rigid ureteroscopes and associated accessories used in urological and gastroenterological procedures. They are designed for visualization and access within the urinary tract during diagnostic and therapeutic interventions.

These devices are supplied non-sterile and require sterilization prior to use. They are reusable instruments intended for use in clinical settings such as hospitals and outpatient surgical centers. The device received FDA 510(k) clearance (K200369) on August 28, 2020, and is classified as a Class II medical device under regulation number 876.1500 with product code FGB.

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. Sources consulted: Ureteroscopes - Urology - Olympus, OES Elite Ureteroscopes and Accessories (K200369) — FDA 510 (k ..., K200369 FDA 510(k) - OES Elite Ureteroscopes and Accessories, OES Elite Ureteroscopes And Accessories 510(k) K200369 - fda.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Olympus Winter & Ibe GmbH

Sources (1)

  • FDA 510(k) K200369 24 fields · synced Sep 22, 2026