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, Hysteroscopic
510(k) Number K173489
Device Name GYN-Pump PH304
Applicant
W.O.M. World of Medicine GmbH
Salzufer 8
Berlin,  DE 10587
Applicant Contact Soeren Markworth
Correspondent
W.O.M. World of Medicine GmbH
Salzufer 8
Berlin,  DE 10587
Correspondent Contact Soeren Markworth
Regulation Number884.1700
Classification Product Code
HIG  
Subsequent Product Code
HET  
Date Received11/13/2017
Decision Date 03/28/2018
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
Recalls CDRH Recalls
-
-