Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Ureteroscope And Accessories, Flexible/Rigid
510(k) Number K260516
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.
301, Bldg. 3, Namtai Inno Park In Guang Ming Ave.
Shenzhen,  CN 518107
Applicant Contact Ye Linbin
Correspondent
MacroLux Medical Technology Co., Ltd.
301, Bldg. 3, Namtai Inno Park In Guang Ming Ave.
Shenzhen,  CN 518107
Correspondent Contact Ye Linbin
Regulation Number876.1500
Classification Product Code
FGB  
Subsequent Product Code
FAJ  
Date Received02/17/2026
Decision Date 07/20/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-