BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR, C50-CB, C50-CBR)— 510(k) K260516

Clearance details

Applicant

MacroLux Medical Technology Co., Ltd.

Product code

Code FGB

Device class

Class 2

Regulation

21 CFR 876.1500

Advisory panel

Gastroenterology, Urology

Date received

2026-02-17

Decision date

2026-07-20

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Shenzhen, CN

• K262488 — Single-Use Video Flexible Ureterorenoscope (RP-U-C06R9, RP-U-C06R3, RP-U-C06S9, RP-U-C06S3)2026-09-09
• K261153 — LithoVue Elite Digital Flexible Ureteroscope System2026-08-26
• K262552 — Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B)2026-08-14
• K253505 — Zamenix P2026-08-07
• K252929 — Single Use Digital Flexible Ureteroscope (7.5F); Videoscope Imaging Processor (Model HV-200)2026-04-09

• K260420 — LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG)2026-04-08
• 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

6

Injury

552

Malfunction

3,922

Other

1

Total

4,481

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 →