LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG)— 510(k) K260420

Clearance details

Applicant

MacroLux Medical Technology Co., Ltd.

Product code

Code EOQ

Device class

Class 2

Regulation

21 CFR 874.4680

Advisory panel

Ear, Nose, Throat

Date received

2026-02-09

Decision date

2026-04-08

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Shenzhen, CN

• K260382 — MONARCH Platform (MON-000008)2026-07-25
• K254037 — LungFlow Airway Catheter2026-07-10
• K253137 — FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840T2026-06-16
• K260565 — SmartClip Delivery Catheter (ADR-1715)2026-05-14
• K252341 — EVIS EXERA III BRONCHOVIDEOSCOPE (3 models)2026-04-23

• K260516 — BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR, C50-CB, C50-CBR)2026-07-20
• K250452 — CoralWell Single-use Ureteral Access Sheath (NS-0835B, NS-0840B, NS-0845B, NS-0855B, NS-0935B, NS-0940B, NS-0945B, NS-0955B, NS-1035B, NS-1040B, NS-1045B, NS-1055B, NS-1135B, NS-1140B, NS-1145B, NS-1155B, NS-1235B, NS-1240B, NS-1245B, NS-1255B, NS-1335B, NS-1340B, NS-1345B, NS-1355B, NS-1435B, NS-1440B, NS-1445B, NS-1455B)2025-06-02
• K240978 — SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G, HO42, HO42-G)2024-08-16
• K240283 — BubbleView Single-Use Digital Flexible Cystoscope (C50-C, C50-CR, C50-CB, C50-CBR) +1 more2024-06-10
• K233779 — LoopView® Single-Use Digital Flexible Bronchoscope (B38, B38-C, B50, B50-C, B58, B58-C), ViewHub® Video Processor (S13)2024-04-05

Death

135

Injury

2,863

Malfunction

21,662

Total

24,660

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →