FDA · official record K260420Substantially Equivalent

LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG)

Name: LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG) — FDA K260420
Creator: MacroLux Medical Technology Co., Ltd.
Keywords: LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG), LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG), K260420, EOQ, FDA

United StatesEOQMacroLux Medical Technology Co., Ltd.

Verified

Official record identity

FDA application number: K260420
Decision date: April 08, 2026
Published decision: Substantially Equivalent

Classification

Product code: EOQ

Published parties

Applicant: MacroLux Medical Technology Co., Ltd.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2026-02-09
Review panel: Ear, Nose, Throat
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 874.4680

About this record

This record preserves an application published in the FDA 510(k) bulk export, including the DEN entries FDA includes in that export. Historical decisions do not establish current marketing status. Product-code harmonization is separate from the original application; joined establishment identifiers are not assigned to the applicant. The complete official export is checked daily and raw evidence is retained.