Cleared Traditional

Instrument basket, for EndoEYE

K171692 · Olympus Winter & Ibe GmbH · General Hospital

Apr 2018

Decision

299d

Days

Class 2

Risk

About This 510(k) Submission

K171692 is an FDA 510(k) clearance for the Instrument basket, for EndoEYE, 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 April 2, 2018, 299 days after receiving the submission on June 7, 2017. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6850.

Submission Details

510(k) Number	K171692 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 07, 2017
Decision Date	April 02, 2018
Days to Decision	299 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