Insighters Single-use Bronchoscope/Insight Bimodel-Integral iS-B12A 4.6/2.0 +3 more— 510(k) K242793
Substantially EquivalentShenzhen Insighters Medical Technology Co., Ltd.
FDA 510(k) clearance K242793 for Insighters Single-use Bronchoscope/Insight Bimodel-Integral iS-B12A 4.6/2.0 +3 more, Substantially Equivalent on 2025-05-28. Applicant: Shenzhen Insighters Medical Technology Co., Ltd.. Device class: 2.
Clearance details
- Device name as filed
- 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.
- Product code
- Code EOQ
- Device class
- Class 2
- Regulation
- 21 CFR 874.4680
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shenzhen, CN
Recent devices under product code EOQ
view allMore clearances from Shenzhen Insighters Medical Technology Co., Ltd.
view allAdverse events under product code EOQ
product code EOQ- Death
- 135
- Injury
- 2,863
- Malfunction
- 21,662
- Total
- 24,660
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.