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 K212786
Device Name LevaLap Laparoscopic Access Device
Applicant
Core Access Surgical Technologies, Inc.
3495 Piedmont Road, NE Building 11, Suite 905
Atlanta,  GA  30305
Applicant Contact Marianne D. Jacklyn
Correspondent
Core Access Surgical Technologies, Inc.
3495 Piedmont Road, NE Building 11, Suite 905
Atlanta,  GA  30305
Correspondent Contact Marianne D. Jacklyn
Regulation Number884.1730
Classification Product Code
HIF  
Date Received09/01/2021
Decision Date 02/23/2022
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
-
-