510(k) K260516
K260516 is an FDA 510(k) premarket notification submitted by MacroLux Medical Technology Co., Ltd. for the device "BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR, C50-CB, C50-CBR)". The FDA issued a decision of Substantially Equivalent on July 20, 2026. The device falls under product code FGB (Ureteroscope And Accessories, Flexible/Rigid), a Class II device regulated under 21 CFR 876.1500. MacroLux Medical Technology Co., Ltd. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 20, 2026
- Date Received
- February 17, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ureteroscope And Accessories, Flexible/Rigid
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type
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).