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 Insufflator, Laparoscopic
510(k) Number K172835
Device Name GRI-Alleset Veress Needle
Applicant
Gri Medical and Electronic Technology Co., Ltd.
105 Honggao Rd., Xiuzhou Industry Zone
Jiaxing,  CN 314031
Applicant Contact Martin Paugh
Correspondent
Sharon Marrow
2907 Cherry Branch Dr.
Knoxville,  TN  37948
Correspondent Contact Sharon Marrow
Regulation Number884.1730
Classification Product Code
HIF  
Date Received09/19/2017
Decision Date 06/11/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-