K242793

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.

510(k) number: K242793
Device name: 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.
Applicant: Shenzhen Insighters Medical Technology Co., Ltd. CN
Product code: EOQ — Bronchoscope (Flexible Or Rigid)
Decision date: 2025-05-28
Date received: 2024-09-16
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: Ear, Nose, Throat

PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain

Also available from FDA: K242793.pdf

Official FDA record: K242793

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.