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 Single-Use Reprocessed Ultrasonic Surgical Instruments
510(k) Number K233471
Device Name Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120); Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 36cm length (HAR1136)
Applicant
Stryker Sustainability Solutions
1810 Drake Dr.
Tempe,  AZ  85283
Applicant Contact Aphrodeja Crutch
Correspondent
Stryker Sustainability Solutions
1810 Drake Dr.
Tempe,  AZ  85283
Correspondent Contact Aphrodeja Crutch
Classification Product Code
NLQ  
Subsequent Product Code
LFL  
Date Received10/25/2023
Decision Date 02/20/2024
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-