FDA 510(k) Applications for Medical Device Product Code "QPB"

FDA 510(k) Number Applicant Device Name Decision Date
K121218 ANDREW TECHNOLOGIES, LLC HYDRASOLVE CONSOLE STERILE TREATMENT KIT REUSABLE CANNULA, 4MM DIA, 26 CM LENGTH, 3 APERTURE REUSABLE CANNULA, 4MM DIA, 12/13/2012
K092066 ANDREW TECHNOLOGIES, LLC PHASER LIPOPLASTY SYSTEM (DUR-01), PHASER DISPOSABLE KIT (DIS-01), PHASER WASTE COLLECTION KIT (WAS-01), PHASER CANNULAE 04/12/2010
K031881 BIOSCULPTURE TECHNOLOGY, INC. AIRBRUSH LIPOSCULPTOR SYSTEM 07/28/2003
K170629 Black & Black Surgical, Inc. VITRUVIAN INFILTRATION PUMP 06/22/2017
K161722 BLACK & BLACK SURGICAL, INC. VITRUVIAN ULTIMATE ASPIRATOR 07/26/2016
K001803 BYRON MEDICAL ACCELERATOR RECIPROCATING CANNULA 08/04/2000
K981172 BYRON MEDICAL LIPOPLASTY/ LIPOSUCTION ASPIRATION AND TUMESCENT INFUSION CANNULAE AND NEEDLES 06/30/1998
K981215 BYRON MEDICAL PSI-TEC LIPOSUCTION ASPIRATOR 07/01/1998
K060089 CELL BIO-SYSTEMS, INC. TULIP DISPOSABLE CANNULAS 04/27/2006
K063235 CYTORI THERAPEUTICS, INC. CYTORI LIPOPLASTY SYSTEM WITH CELASE REAGENT 01/24/2007
K101413 EUROMI SA EUROMI EVA SP6 12/16/2010
K010311 EUROMI SA LIPOMATIC; LIPOMATIC LIPOSUCTION DEVICE 06/29/2001
K032802 HK SURGICAL, INC. HK LIPOSUCTION ASPIRATOR, MODEL AP-III & AP230-III 11/19/2003
K082025 HUMAN MED AG BODY-JET 08/13/2008
K132353 INEX SUCTION LIPOPLASTY ACCESSORIES 07/30/2014
K012236 KMI KOLSTER METHODS, INC. STARS2000 POWER CANNULA 11/19/2001
K093067 LIPOSE CORP. LIPOSE DISPOSABLE CANNULA 12/29/2009
K980763 LYSONIX, INC. LYSONIX LIPOPLASTY ACCESS PORT 05/28/1998
K980771 LYSONIX, INC. LYSONIX SUCTION LIPOPLASTY SYSTEM 07/13/1998
K042261 MACROPORE BIOSURGERY, INC. MACROPORE PURICEL LIPOPLASTY SYSTEM 09/20/2004
K150134 MEDELA AG Basic, Dominant Flex, KV-6 04/21/2015
K063336 MEDELA AG MEDELA DOMINANT 50 LIPO, MODEL 600-5706 02/26/2007
K081593 MEDICAL DEVICE RESOURCE CORP. POWER ASPIRATOR, MODEL LS2 OR LS2DP 07/23/2008
K010666 MEDTRONIC XOMED, INC. XPS 3000 SYSTEM WITH RECIPROCATING ADAPTER AND SUCTION CANNULAE 05/07/2001
K981527 MENTOR CORP. MENTOR PATHWAY INTRODUCER/DILATOR 07/09/1998
K004005 MENTOR CORP. MENTOR ULTRASOUND-ASSISTED TISSUE REMOVAL SYSTEM (CURRENT), MENTOR CONTOUR GENESIS SYSTEM (PROPOSED) 10/12/2001
K192694 MicroAire Surgical Instruments PAL Single-Use Cannulas 05/14/2020
K981922 MICROAIRE SURGICAL INSTRUMENTS, INC. LIGHT DUTY PNEUMATIC INSTRUMENT MODEL NUMBER PAD-100, HEAVY DUTY PNEUMATIC INSTRUMENT MODEL PAD-200, LIGHT DUTY ELECTRI 12/10/1998
K113128 MICROAIRE SURGICAL INSTRUMENTS, LLC MICROAIRE SURGICAL INSTRUMENTS LLC 08/17/2012
K220318 MicroAire Surgical Instruments, LLC PAL Infiltration System 10/14/2022
K171286 MicroAire Surgical Instruments, LLC PAL Multi-Use Cannulas and PAL Manual Wand 10/13/2017
K212024 MicroAire Surgical Instruments, LLC PAL System 06/10/2022
K081039 MILLENNIUM MEDICAL TECHNOLOGIES, INC. LIPO CANNULA 07/10/2008
K041058 MISONIX, INC. MISONIX INC. LYSONIX 2000/3000 ULTRASONIC SURGICAL ASPIRATOR SYSTEMS 05/17/2004
K170329 Modela AG Basic, Dominant Flex 03/24/2017
K053451 MOELLER MEDICAL GMBH & CO. KG LIPOSAT (INFILTRATION PUMP), MODEL 00 002 274; VACUSAT (SUCTION UNIT), MODEL 00 002 252 (220 V), 00 002 318 (110 V); 08/25/2006
K072793 MOELLER MEDICAL GMBH & CO. KG LIPOSAT BASIC (INFILTRATION PUMP), MODEL 92-007 688 03/04/2008
K113795 NORMAN M. BLACK III SUCTION LIPOLASTY ACCESSORIES 08/07/2012
K200168 Puregraft LLC Dermapose Access 04/22/2020
K012042 RELIANCE MEDICAL CORP. KINETIC CANNULA 09/20/2001
K190555 Solta Medical PowerX Lipo System 05/01/2019
K190551 Solta Medical VASERlipo System 05/01/2019
K052183 SORING GMBH MEDIZINTECHNIK SORING GMBH SONOCA LIPO 10/07/2005
K110255 SOUND SURGICAL TECHNOLOGIES LLC. SOUND SURGICAL TECHNOLOGIES LLC POWERX LIPO SYSTEM 04/04/2011
K110306 SOUND SURGICAL TECHNOLOGIES LLC. SOUND SURGICAL VASER 2.1 LIPO SYSTEM 06/23/2011
K022051 SOUND SURGICAL TECHNOLOGIES LLC. SOUNDVASER SYSTEM 09/11/2002
K990602 TECSA TECHNICAL SERVICES RICHTER LIPOPLASTY CANNULAS AND ACCESSORIES 07/01/1999
K992282 XOMED, INC. MICRO-FRANCE LIPOSUCTION CANNULAS 09/23/1999
K992855 XOMED, INC. XPS STRAIGHTSHOT OR MODEL 2000 MICRODEBRIDER SYSTEM OR XPS POWERSCULPT 01/21/2000


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