510(k) K242793 · EOQ Bronchoscope (Flexible Or Rigid)
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., Shenzhen, CN |
| Decision | Substantially Equivalent, May 28, 2025 |
| Received | Sep 16, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K242793
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.