K260420
- 510(k) number
- K260420
- Device name
- LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG)
- Applicant
- MacroLux Medical Technology Co., Ltd. CN
- Product code
- EOQ — Bronchoscope (Flexible Or Rigid)
- Decision date
- 2026-04-08
- Date received
- 2026-02-09
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ear, Nose, Throat
PDFDownload 510(k) SummaryArchived here · 2.9 MB · U.S. public domain
Also available from FDA: K260420.pdf
Official FDA record: K260420
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.