Cleared Traditional

Insighters? Single-use Bronchoscope/Insight Bimodel-Integral iS-B12A 4.6/2.0; Insighters? Single-use Bronchoscope/Insight Bimodel-Integral iS-B22A 5.5 /2.6; Insighters? Single-use Bronchoscope/Insight Bimodel-Integral iS-B26A 6.0/3.0; Insighters? Insight Workstation iS-PF1.

K242793 · Shenzhen Insighters Medical Technology Co., Ltd. · Ear, Nose, Throat

May 2025

Decision

254d

Days

Class 2

Risk

About This 510(k) Submission

K242793 is an FDA 510(k) clearance for the Insighters? Single-use Bronchoscope/Insight Bimodel-Integral iS-B12A 4.6/2.0; Insighters? Single-use Bronchoscope/Insight Bimodel-Integral iS-B22A 5.5 /2.6; Insighters? Single-use Bronchoscope/Insight Bimodel-Integral iS-B26A 6.0/3.0; Insighters? Insight Workstation iS-PF1., a Bronchoscope (flexible Or Rigid) (Class II — Special Controls, product code EOQ), submitted by Shenzhen Insighters Medical Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on May 28, 2025, 254 days after receiving the submission on September 16, 2024. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4680.

Submission Details

510(k) Number	K242793 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 16, 2024
Decision Date	May 28, 2025
Days to Decision	254 days
Submission Type	Traditional
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).