Cleared Special

KARL STORZ Flexible Intubation Video Endoscope ? Sterile (FIVE-S) (0916612)

K251731 · Karl Storz SE & CO. KG · Ear, Nose, Throat

Dec 2025

Decision

182d

Days

Class 2

Risk

About This 510(k) Submission

K251731 is an FDA 510(k) clearance for the KARL STORZ Flexible Intubation Video Endoscope ? Sterile (FIVE-S) (0916612), a Bronchoscope (flexible Or Rigid) (Class II — Special Controls, product code EOQ), submitted by Karl Storz SE & CO. KG (Tuttlingen, DE). The FDA issued a Cleared decision on December 5, 2025, 182 days after receiving the submission on June 6, 2025. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4680.

Submission Details

510(k) Number	K251731 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 06, 2025
Decision Date	December 05, 2025
Days to Decision	182 days
Submission Type	Special
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF

Device Classification

Product Code	EOQ — Bronchoscope (flexible Or Rigid)
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 874.4680
Definition	A Bronchoscope (flexible Or Rigid) And Accessories Is A Tubular Endoscopic Device With Any Of A Group Of Accessory Devices Which Attach To The Bronchoscope And Is Intended To Examine Or Treat The Larynx And Tracheobronchial Tree. If The Device Is Reprocessed, Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission. 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).