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 K242536
Device Name TauTona Pneumoperitoneum Assist Device (TPAD)
Applicant
Tautona Group
604 Fifth Ave.
Suite D
Redwood City,  CA  94063
Applicant Contact Mike Blanchette
Correspondent
Tautona Group
604 Fifth Ave.
Suite D
Redwood City,  CA  94063
Correspondent Contact Mike Blanchette
Regulation Number884.1730
Classification Product Code
HIF  
Date Received08/26/2024
Decision Date 10/15/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Clinical Trials NCT04392635
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-