Cleared Traditional

Instrument tray, for semi-rigid ureteroscope

K203492 · Olympus Winter & Ibe GmbH · General Hospital

Sep 2021

Decision

300d

Days

Class 2

Risk

About This 510(k) Submission

K203492 is an FDA 510(k) clearance for the Instrument tray, for semi-rigid ureteroscope, a Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (Class II — Special Controls, product code KCT), submitted by Olympus Winter & Ibe GmbH (Hamburg, DE). The FDA issued a Cleared decision on September 15, 2021, 300 days after receiving the submission on November 19, 2020. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6850.

Submission Details

510(k) Number	K203492 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 19, 2020
Decision Date	September 15, 2021
Days to Decision	300 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	KCT — Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 880.6850