Cleared Traditional

K193517 - ViziShot 2 FLEX
(FDA 510(k) Clearance)

K193517 · Olympus Surgical Technologies America · Anesthesiology

Mar 2020

Decision

90d

Days

Class 2

Risk

K193517 is an FDA 510(k) clearance for the ViziShot 2 FLEX. This device is classified as a Bronchoscope Accessory (Class II — Special Controls, product code KTI).

Submitted by Olympus Surgical Technologies America (Southborough, US). The FDA issued a Cleared decision on March 18, 2020, 90 days after receiving the submission on December 19, 2019.

This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 874.4680. If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type 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)..

Submission Details

510(k) Number	K193517 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 19, 2019
Decision Date	March 18, 2020
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF

Device Classification

Product Code	KTI — Bronchoscope Accessory
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 874.4680
Definition	If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type 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).