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 K241401
Device Name Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control
Applicant
Stryker Endoscopy
5900 Optical Ct
San Jose,  CA  95138
Applicant Contact Sekar Divya
Correspondent
Stryker Endoscopy
5900 Optical Ct
San Jose,  CA  95138
Correspondent Contact Sekar Divya
Regulation Number876.1500
Classification Product Code
GCJ  
Subsequent Product Code
HRX  
Date Received05/17/2024
Decision Date 08/15/2024
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
-
-