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510(k) K200369

OES Elite Ureteroscopes and Accessories by Olympus Winter & Ibe GmbH — Product Code FGB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 28, 2020
Date Received
February 14, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ureteroscope And Accessories, Flexible/Rigid
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To perform various diagnostic and therapeutic procedures within the urinary tract. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

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  • K252703 — LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard with pressure (September 24, 2025)
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