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 Only Blood Lancet With An Integral Sharps Injury Prevention Feature
510(k) Number K231124
Device Name Unistik® 3 Single-Use Safety Lancets:- Extra (21G), Normal (23G), Comfort (28G), Gentle (30G)
Applicant
Owen Mumford Ltd
Brook Hill
Woodstock,  GB OX20 1TU
Applicant Contact Darren Mansell
Correspondent
Owen Mumford Ltd
Brook Hill
Woodstock,  GB OX20 1TU
Correspondent Contact Darren Mansell
Regulation Number878.4850
Classification Product Code
FMK  
Date Received04/20/2023
Decision Date 06/27/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-