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 laparoscope, general & plastic surgery
510(k) Number K160393
Device Name AdTec
Applicant
AESCULAP, INC.
3773 CORPORATE PARKWAY
Center Valley,  PA  18034
Applicant Contact Jessica Stigliano
Correspondent
AESCULAP, INC.
3773 CORPORATE PARKWAY
Center Valley,  PA  18034
Correspondent Contact Jessica Stigliano
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received02/11/2016
Decision Date 05/26/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-