BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR, C50-CB, C50-CBR)
FDA 510(k) K260516 · MacroLux Medical Technology Co., Ltd.
Submission
- Device name
- BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR, C50-CB, C50-CBR)
- Applicant
- MacroLux Medical Technology Co., Ltd.
Shenzhen, CN - Received
- February 17, 2026
- Decision date
- July 20, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FGB – Ureteroscope And Accessories, Flexible/Rigid
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
To perform various diagnostic and therapeutic procedures within the urinary tract. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Other 510(k)s with product code FGB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262488 | Single-Use Video Flexible Ureterorenoscope (RP-U-C06R9, RP-U-C06R3, RP-U-C06S9…FGB · Traditional | Guangzhou Red Pine Medical Instrument Co., Ltd. | 09/09/2026SE |
| K261153 | LithoVue Elite Digital Flexible Ureteroscope SystemFGB · Traditional | Boston Scientific Corporation | 08/26/2026SE |
| K262552 | Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B)FGB · Special | Scivita Medical Technology Co., Ltd. | 08/14/2026SE |
| K253505 | Zamenix PFGB · Traditional | Roen Surgical, Inc. | 08/07/2026SE |
| K252929 | Single Use Digital Flexible Ureteroscope (7.5F); Videoscope Imaging Processor (Model…FGB · Traditional | Anhui Happiness Workshop Instruments Co., Ltd. | 04/09/2026SE |
| K260013 | CVAC Image ProcessorFGB · Traditional | Calyxo, Inc. | 03/06/2026SE |
| K252468 | Single-use Digital Flexible Ureteroscope (GY-UR9.3); Single-use Digital Flexible…FGB · Traditional | Zhejiang Geyi Medical Instrument Co., Ltd. | 12/16/2025SE |
| K251951 | Single-Use Video Flexible Ureterorenoscope (RP-U-C03R9, RP-U-C03R3, RP-U-C03S9…FGB · Traditional | Guangzhou Red Pine Medical Instrument Co., Ltd. | 12/16/2025SE |
| K253411 | Miniature Telescope for Urology (27033AA)FGB · Traditional | Karl Storz SE & CO. KG | 11/18/2025SE |
| K250917 | Flexible Ureterorenoscope system (Electronic Endoscope Image Processor, model:…FGB · Traditional | Shenzhen Sanping Image Technology Co., Ltd. | 10/31/2025SE |
More from Shenzhen Sanping Image Technology Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K260420 | LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG)EOQ · Traditional | 04/08/2026SE |
| K250452 | CoralWell Single-use Ureteral Access Sheath (NS-0835B, NS-0840B, NS-0845B, NS-0855B…FED · Traditional | 06/02/2025SE |
| K240978 | SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G…HIH · Traditional | 08/16/2024SE |
| K240283 | BubbleView Single-Use Digital Flexible Cystoscope (C50-C, C50-CR, C50-CB, C50-CBR)…FAJ · Traditional | 06/10/2024SE |
| K233779 | LoopView® Single-Use Digital Flexible Bronchoscope (B38, B38-C, B50, B50-C, B58, B58-C)…EOQ · Traditional | 04/05/2024SE |
| K231774 | CoralView® Single-use Digital Flexible Ureteroscope (U10); CoralView® Single-use Digital…FGB · Traditional | 01/11/2024SE |
Questions and answers
When was BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR, C50-CB, C50-CBR) cleared by the FDA?
BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR, C50-CB, C50-CBR) (K260516) received a 510(k) decision of Substantially Equivalent on July 20, 2026, 153 days after the submission was received.
What is the product code of K260516?
The FDA product code is FGB – Ureteroscope And Accessories, Flexible/Rigid, a Class II (moderate risk) device regulated under 21 CFR 876.1500.