• 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 K231042
Device Name Disposable Laparoscopic Trocar
Changzhou Ankang Medical Instruments Co., Ltd.
A4 Standard Workshop, Hutang Science and Technology
Industrial Park, Hutang Town, Wujin District
Changzhou,  CN 213162
Applicant Contact Tingting Cao
Mid-Link Consulting Co.,Ltd
P.O.BOX 120-119
Shanghai,  CN 200120
Correspondent Contact Diana Hong
Regulation Number876.1500
Classification Product Code
Date Received04/12/2023
Decision Date 06/08/2023
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