FDA 510(k) Applications for Medical Device Product Code "NLQ"
(Scalpel, Ultrasonic, Reprocessed)

FDA 510(k) Number Applicant Device Name Decision Date
K043358 ALLIANCE MEDICAL CORP. REPROCESSED ULTRASONIC SCALPELS 06/06/2005
K093702 ASCENT HEALTHCARE SOLUTIONS REPROCESSED ULTRASONIC COAGULATING SHEARS 03/04/2010
K100537 ASCENT HEALTHCARE SOLUTIONS REPROCESSED ULTRASONIC CURVED SHEARS WITH TORQUE WRENCH AND GRIP ASSIST MODEL FCS9, TWBLUE, GABLUE 05/12/2010
K030598 MEDISISS MEDISISS REPROCESSED ULTRASONIC SURGICAL INSTRUMENTS 01/23/2004
K143562 STERILMED, INC. Reprocessed Cordless Ultrasonic Dissection Device 05/20/2015
K012571 STERILMED, INC. REPROCESSED HARMONIC 11/07/2001
K083060 STERILMED, INC. REPROCESSED HARMONIC SCALPEL 01/09/2009
K111794 STERILMED, INC. REPROCESSED HARMONIC SCALPEL 01/11/2012
K050343 STERILMED, INC. REPROCESSED HARMONIC SCALPELS 04/12/2005
K132566 STERILMED, INC. REPROCESSED HARMONIC SHEAR 06/14/2014
K133672 STRYKER SUSTAINABILITY SOLUTIONS REPROCESSED HARMONIC ACE SHEARS WITHOUT ADAPTIVE TISSUE TECHNOLOGY 05/01/2014
K161693 STRYKER SUSTAINABILITY SOLUTIONS Reprocessed HARMONIC ACE+7, 5 mm Diameter Shears with Advanced Hemostasis 02/23/2017
K170456 Stryker Sustainability Solutions Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology 04/05/2017
K173627 Surgical Instrument Service and Savings Inc Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector 07/12/2018
K170955 Surgical Instrument Service and Savings Inc (dba Medline ReN Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector 07/03/2017
K151405 Surgical Instrument Services and Savings(dba Medline ReNewal Medline ReNewal Reprocessed Harmonic ACE + Shears without Adaptive Tissue Technology 01/26/2016
K150524 Surgical Instrument Services and Savings, Inc Medline ReNewal Reprocessed Harmonic FOCUS+ Shears without Adaptive Tissue Technology 12/16/2015
K124033 SURGICAL INSTRUMENTS SERVICE AND SAVINGS, INC. MEDISISS REPROCESSED ULTRASONIC INSTRUMENTS 01/07/2014
K043315 VANGUARD MEDICAL CONCEPTS, INC. VANGUARD REPROCESSED HAND-ACTIVATED ULTRASONIC SCALPEL 03/22/2005
K043225 VANGUARD MEDICAL CONCEPTS, INC. VANGUARD REPROCESSED ULTRASONIC SCALPEL 03/22/2005


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact