BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR, C50-CB, C50-CBR)— 510(k) K260516
Substantially EquivalentMacroLux Medical Technology Co., Ltd.
FDA 510(k) clearance K260516 for BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR, C50-CB, C50-CBR), Substantially Equivalent on 2026-07-20. Applicant: MacroLux Medical Technology Co., Ltd.. Device class: 2.
Summary
MacroLux Medical Technology's BubbleView Single-Use Digital Flexible Cystoscope comes in six models (C38-CS, C38-CRS, C50-C, C50-CR, C50-CB, and C50-CBR). It's filed under FGB, flexible or rigid ureteroscopes and accessories; the device name says cystoscope, and the record doesn't explain the fit.
Class II, 21 CFR 876.1500. Gastroenterology and Urology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
MacroLux filed from Shenzhen, China. Review took 153 calendar days (February 17 to July 20, 2026).
Clearance details
- Applicant
- MacroLux Medical Technology Co., Ltd.
- Product code
- Product code FGB
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shenzhen, CN
Recent devices under product code FGB
view all- K262437 — Single-use Digital Flexible Ureteroscope (GY-UR6.3); Single-use Digital Flexible Ureteroscope (GY-UR6.3A)
- K260708 — Vein360 Reprocessed LithoVue Digital Flexible Ureteroscope (Standard Deflection) +1 more
- K261447 — CVAC® Aspiration System
- K262488 — Single-Use Video Flexible Ureterorenoscope (RP-U-C06R9, RP-U-C06R3, RP-U-C06S9, RP-U-C06S3)
- K261153 — LithoVue Elite Digital Flexible Ureteroscope System
More clearances from MacroLux Medical Technology Co., Ltd.
view all- K260420 — LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG)
- 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)
- K240978 — SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G, HO42, HO42-G)
- K240283 — BubbleView Single-Use Digital Flexible Cystoscope (C50-C, C50-CR, C50-CB, C50-CBR) +1 more
- K233779 — LoopView® Single-Use Digital Flexible Bronchoscope (B38, B38-C, B50, B50-C, B58, B58-C), ViewHub® Video Processor (S13)
Adverse events under product code FGB
product code FGB- Death
- 6
- Injury
- 552
- Malfunction
- 3,922
- Other
- 1
- Total
- 4,481
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.