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 Endoscopic Grasping/Cutting Instrument, Non-Powered
510(k) Number K191900
Device Name Single Use Grasping Forceps
Applicant
Zhejiang Chuangxiang Medical Technology Co., Ltd.
301b, #22, Xinyan Rd.
Hanzhou,  CN 311100
Applicant Contact Lucius Long
Correspondent
Zhejiang Chuangxiang Medical Technology Co., Ltd.
301b, #22, Xinyan Rd.
Hanzhou,  CN 311100
Correspondent Contact Lucius Long
Regulation Number876.1500
Classification Product Code
OCZ  
Date Received07/16/2019
Decision Date 03/27/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-