• 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 K193339
Device Name GTK Veress Needles
Guangzhou T.K Medical Instrument Co., Ltd.
A601, Guangzhou International Business Incubator, Guangzhou
Science Park
Guangzhou,  CN 510663
Applicant Contact Tracy Weng
Shenzhen Joyantech Consulting Co., Ltd
1713A, Block A, Zhongguan Times Square, Liuxian Avenue,
Xili Town, Nanshan
Shenzhen,  CN 518000
Correspondent Contact Christy Young
Regulation Number884.1730
Classification Product Code
Subsequent Product Code
Date Received12/02/2019
Decision Date 01/30/2020
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