• 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 K142700
Device Name InsufflatOR Needle
Unit 7, 6-8 Macquarie Drive
Thomastown,  AU 3095
Applicant Contact Kevin MacDonald
MacDonald Consulting
229 Marvilla Circle
Pacifica,  CA  94044
Correspondent Contact Kevin MacDonald
Regulation Number884.1730
Classification Product Code
Date Received09/22/2014
Decision Date 12/19/2014
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