FDA 510(k)

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

Numéro K : K260420 · 2026-04-08

DemandeurMacroLux Medical Technology Co., Ltd.

Date de décision2026-04-08

Code produitEOQ

Comité consultatifEN

DécisionSubstantially Equivalent

Résumé du dispositif

LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG) is the device name listed in this FDA 510(k) record. The listed applicant is MacroLux Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-04-08 under 510(k) number K260420. The device is classified under product code EOQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG)?

LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG) is a medical device that received FDA 510(k) clearance on 2026-04-08. The listed applicant is MacroLux Medical Technology Co., Ltd.. The 510(k) number is K260420.

When did LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG) receive FDA 510(k) clearance?

LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG) received FDA 510(k) clearance on 2026-04-08, under 510(k) number K260420.

Who is the listed applicant for LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG)?

The FDA 510(k) record lists MacroLux Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG)?

The FDA product code for LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG) is EOQ.

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Autres dossiers indiquant MacroLux Medical Technology Co., Ltd. en tant que demandeur

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Dispositifs connexes (Code : EOQ)

K261637Single-use Flexible BronchoscopeHunan Vathin Medical Instrument Co., Ltd.K260309Ambu® aScope™ 5 Broncho 2.7/1.2; Ambu® aScope™ 5 Broncho 4.2/2.2; Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler SetAmbu A/S K2540263.8mm Slim ProVu Video Bronchoscope (090-02-0038U); 5.0mm Regular ProVu Video Bronchoscope (090-02-0050U); 6.0mm Large ProVu Video Bronchoscope (090-02-0060U); ProVu Video Bronchoscope 8 display (040-07-0082U)Flexicare Medical Limited.K260382MONARCH™ Platform (MON-000008)Auris Health, Inc.K254037LungFlow Airway CatheterFree Flow Medical, Inc.K253137FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840TFujifilm Corporation

Source officielle

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