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 K161421
FOIA Releasable 510(k) K161421
Device Name Single Use Surgical Suction Irrigator
Applicant
Jiangsu Haize Medical Scientific Development Co., Ltd.
#99, Furongzhongsan Rd., Xishan Economical Development
Zone
Wuxi,  CN 214000
Applicant Contact Vivian Sun
Correspondent
Jiangsu Haize Medical Scientific Development Co., Ltd.
#99, Furongzhongsan Rd., Xishan Economical Development
Zone
Wuxi,  CN 214000
Correspondent Contact Vivian Sun
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received05/23/2016
Decision Date 06/24/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-