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 Laparoscope, General & Plastic Surgery
510(k) Number K252858
Device Name 4K UHD Endoscopy Camera System (KMS-4K-2088, KMS-4K-2188, KMS-4K-2288)
Applicant
Kms Medical Technology Co., Ltd.
Bldg. A1 And A2, #769 Qingzhuhu Rd., Qingzhuhu
Sub-District, Kaifu
Changsha,  CN 410201
Applicant Contact Yi Dai
Correspondent
Kms Medical Technology Co., Ltd.
Bldg. A1 And A2, #769 Qingzhuhu Rd., Qingzhuhu
Sub-District, Kaifu
Changsha,  CN 410201
Correspondent Contact Yi Dai
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received09/09/2025
Decision Date 04/30/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-