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 K201434
Device Name Connected OR Hub with Voice Control, Connected OR Hub with Device Control
Applicant
Stryker
5900 Optical Court
San Jose,  CA  95131
Applicant Contact Meagan Jones
Correspondent
Stryker
5900 Optical Court
San Jose,  CA  95131
Correspondent Contact Meagan Jones
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received06/01/2020
Decision Date 07/28/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-