meddevicedb.com FDA Device Reference

Review Panel

General, Plastic Surgery FDA 510(k) Clearances & Devices

Cleared Devices
16,323
Product Codes (page)
33
Latest Decision
2002-05-02

Clearances · page 79 of 164

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K021117 TTI THERMOMED MODEL 1.8 INSTRUMENT Thermosurgery Technologies, Inc. GEI Class II 2002-05-02
K012279 PATTON TRIPOL Patton Medical Corp. GEI Class II 2002-04-30
K020705 SIIS#1 TISSUE SUSPENSION SYSTEM Tag Medical Products OTN Class II 2002-04-26
K012214 CRYOPEN AND ACCESSORIES Cimex Biotech, LLC GEH Class II 2002-04-26
K020901 SERRALSILK Serral, S.A. DE C.V. GAP Class II 2002-04-26
K020919 ATRICURE BIPOLAR SYSTEM, MODELS ASU1, ASU2, ASU3, LHP1, LHP2, RHP1 AtriCure, Inc. GEI Class II 2002-04-19
K020918 ELASTYFREE SYNTHETIC POWDER-FREE SURGICAL GLOVE Eci Medical Technologies, Inc. KGO Class I 2002-04-19
K020940 SUPERSTITCH VASCULAR SUTURING DEVICE, 6 FRENCH, MODELS 06-15-00X; MID-LENGTH 06-25-00X Sutura, Inc. GAW Class II 2002-04-17
K021077 MEGA 2000 SOFT PATIENT RETURN ELECTRODE PAD Megadyne Medical Products, Inc. GEI Class II 2002-04-17
K021076 PRIMAGARD YELLOW SURGICAL MASK, PLEATED, TIE-ON, PM4-307; PRIMAGARD YELLOW SURGICAL MASK, PLEATED, EAR-LOOP,PM4-308; PRM Primeline Medical Products, Inc. FXX Class II 2002-04-16
K013300 MAXIFLEX FIBER OPTIC ENERGY DELIVERY SYSTEM Technology Delivery Systems, Inc. GEX Class II 2002-04-16
K021046 COBRA COOLED SURGICAL PROBE, MODEL 1596X Boston Scientific Corp GEI Class II 2002-04-16
K020146 SERRALNYL Serral, S.A. DE C.V. GAR Class II 2002-04-15
K020435 WOUND PROTECTOR/RETRACTOR Applied Medical Resources Corp. KKX Class II 2002-04-15
K020697 DEPILASE TWIN YAG LASER SYSTEM Depilase Group , Ltd. GEX Class II 2002-04-12
K020135 CONMED SYSTEM 2000 ELECTROSURGICAL GENERATOR, REF: 60-8002; CONMED ESU CART, REF: 60-6120 Conmedcorp GEI Class II 2002-04-12
K020186 CONMED SYSTEM 5000 ESU Conmedcorp GEI Class II 2002-04-12
K020276 8 GAUGE MICROMARK II TISSUE MARKER, MODELS C1540 & C1535 Ethicon Endo-Surgery, Inc. NEU Class II 2002-04-12
K020099 MEGA BEAM/CERALAS NONSTERILE COLLIMATING HANDPIECE Biolitec, Inc. GEX Class II 2002-04-11
K020343 SURGASSIST SYSTEM; WIRELESS REMOTE CONTROL (COMPONENT); WIRED REMOTE CONTROL Power Medical Interventions, Inc. GDW Class II 2002-04-10
K020654 STRATASIS SLING KIT Cook Biotech, Inc. PAG Class II 2002-04-09
K020072 ATHOS LASER Quantel Medical GEX Class II 2002-04-09
K020832 ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOT CONTROL, POWER CORD, WANDS Arthrocare Corp. GEI Class II 2002-04-09
K020071 VIRIDIS DERMA LASER Quantel Medical GEX Class II 2002-04-05
K020047 RUBICOR BREAST BIOPSY DEVICE Rubicor Medical, Inc. GEI Class II 2002-04-05
K020067 GYRUS ENT SOMNOPLASTY GENERATOR Gyrus Ent LLC GEI Class II 2002-04-04
K013369 RESECTION ABLATOR Linvatec Corp. GEI Class II 2002-04-04
K020110 MODIFICATION TO TRELEX MESH SURGICAL MESH Boston Scientific OTN Class II 2002-04-03
K020455 TISSUEMEND SOFT TISSUE REPAIR MATRIX Tei Biosciences, Inc. FTM Class II 2002-04-03
K020308 REGENT BIOGEL SKINSENSE STERILE POWDER-FREE, SYNTHETIC POLYISOPRENE SURGEON'S GLOVE Ssl America'S, Inc. KGO Class I 2002-04-03
K020973 EX-308 EXCIMER LASER FOR PHOTOTHERAPY TREATMENT OF VITILIGO Surgilight, Inc. GEX Class II 2002-03-29
K014290 ENTEC PLASMA WANDS Arthrocare Corp. GEI Class II 2002-03-28
K020622 ARTHROCARE CONTROLLER (SYSTEM 2000 AND 8000); ARTHROCARE CABLE; FOOT CONTROL; POWER CORD; AND WANDS Arthrocare Corp. GEI Class II 2002-03-28
K020621 ARTHROCARE CONTROLLER; ARTHROCARE CABLE; FOOT CONTROL; POWER CORD; WANDS Arthrocare Corp. GEY Class I 2002-03-28
K020663 MODIFICATION TO SPARC SLING SYSTEM American Medical Systems, Inc. OTN Class II 2002-03-28
K020031 EN-BLOC BIOPSY SYSTEM, MODELS 777-110, 777-120, 770-001, 777002, 777-006, 777-301, 777-302 Neothermia Corp. GEI Class II 2002-03-27
K014260 TISSUELINK SOLID CYLINDER MONOPOLAR DEVICE Tissuelink Medical, Inc. GEI Class II 2002-03-27
K014272 PERIOLASE ND:YAG DENTAL LASER SYSTEM Millennium Dental Technologies, Inc. GEX Class II 2002-03-27
K014236 CLINICON WAVEGUIDE PLATFORM WITH INTERCONNECT FOR LUXAR ACCESSORIES Clinicon Corp. GEX Class II 2002-03-26
K014253 DERMACHILLER 4 Paradigm Trex, LLC GEX Class II 2002-03-26
K014251 NTERO HOTROD SYSTEM Ntero Surgical, Inc. GEI Class II 2002-03-26
K020007 SAFYRE SLING SYSTEM Promedon OTN Class II 2002-03-21
K014216 SECCA SYSTEM Curon Medical, Inc. GEI Class II 2002-03-21
K020557 ARTHROCARE CONTROLLER; ARTHROCARE CABLE; FOOT CONTROL; POWER CORD; WANDS Arthrocare Corp. GEI Class II 2002-03-21
K014207 REPOSABLE INSTRUMENT SYSTEM, MODELS MF001-MF083 Aesculap, Inc. GEI Class II 2002-03-21
K014172 NELSON ELECTROSURGICAL UNIT, MODEL GN640 Aesculap, Inc. GEI Class II 2002-03-19
K013201 CARDIOFOCUS DIODE LASER SYSTEM, MODELS 60R, 60NR, 30NR Cardiofocus, Inc. GEX Class II 2002-03-18
K020593 CONVERTORS SMS POLYOLEFIN GOWN Allegiance Healthcare Corp. FYA Class II 2002-03-18
K020049 FORTAFLEX SURGICAL MESH Organogenesis, Inc. FTM Class II 2002-03-18
K020126 MODIFICATION TO SURX RADIOFREQUENCY ELECTROSURGICAL GENERATOR SYSTEM AND ACCESSORIES (SURX TV SYSTEM) Surx, Inc. MUK Class II 2002-03-15
K012350 MEDPOR PLUS SURGICAL IMPLANT BIOMATERIAL Porex Surgical, Inc. FWP Class II 2002-03-14
K014230 STERILE POWDER FREE LATEX SURGEON GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS) Supermax Glove Manufacturing Sdn Bhd KGO Class I 2002-03-13
K020480 RBM Smith & Nephew, Inc. KGS Class I 2002-03-12
K020265 SERRALENE, MODEL CATALOG NO 1S Serral, S.A. DE C.V. GAW Class II 2002-03-08
K014286 SALUTE, MODEL 3022 Onux Medical, Inc. GDW Class II 2002-03-08
K014057 DERMASTAR ER:YAG LASER SYSTEM Asclepion-Meditec AG GEX Class II 2002-03-08
K020470 MODIFICATION TO CORLINK AUTOMATED ANASTOMOTIC DEVICE Bypass , Ltd. FZP Class II 2002-03-08
K020605 SANARUS VISICA TREATMENT SYSTEM Sanarus Medical, Inc. GEH Class II 2002-03-08
K014035 COOLTOUCH AND COOLTOUCH-II ND:YAG LASER SYSTEMS Cooltouch Corp. GEX Class II 2002-03-07
K012957 TOWEL DRAPE, MODELS 4409, 4410 Dynarex Corp. KKX Class II 2002-03-06
K013680 CARBODISSECTING ENDOSCOPE Endo Surgical Devices, Inc. GEI Class II 2002-03-04
K013941 PULSION FS LASER KERATOME Intra Lase Corp. GEX Class II 2002-02-27
K013946 FLEX 10 ACCESSORY FOR THE AFX MICROWAVE ABLATION SYSTEM Afx, Inc. NEY Class II 2002-02-27
K013990 LIFESTITCH SUTURING DEVICE Edwards Lifesciences, LLC GAT Class II 2002-02-27
K013216 DIODENT DENTAL LASER SYSTEM Continuum Electro-Optics, Inc. GEX Class II 2002-02-27
K020463 DEPILASE YAG LASE PLUS LASER SYSTEM Depilase Group , Ltd. GEX Class II 2002-02-27
K013940 LASER SYSTEM YELLOWSTAR Asclepion-Meditec AG GEX Class II 2002-02-26
K014201 AARON REUSABLE ELECTROSURGICAL ELECTRODE Aaron Medical Industries GEI Class II 2002-02-25
K020412 DEPILASE TWIN LASE LASER SYSTEM Depilase Group , Ltd. GEX Class II 2002-02-22
K011708 MODIFICATION TO WARTNER WART REMOVAL SYSTEM Wartner Medical Products GEH Class II 2002-02-20
K011273 SI ASCOPE Astron Clinica Limited PSN Class II 2002-02-20
K014239 MEDSURG EQUIPMENT COVERS International Medsurg Connection MMP Class II 2002-02-19
K013825 CANDELA SMOOTHBEAM LASER SYSTEM Candela Corp. GEX Class II 2002-02-15
K020304 DISPOSABLE LIGHT HANDLE AND ADAPTOR Aspen Surgical Products, Inc. FTA Class II 2002-02-14
K014036 MEDTRADE PRODUCTS SILICONE SCAR THERAPY GEL, SPENCO MEDICAL CORP. 2ND SKIN SILICONE SCAR THERAPY GEL, MODEL 09916030. Medtrade Products , Ltd. MDA Class I 2002-02-14
K014288 DERMGRIP POWDER FREE POLYMER COATED LATEX SURGEON'S GLOVES,STERILE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM ORS Wrp Specialty Products Sdn. Bhd. KGO Class I 2002-02-13
K013904 BMC RADIO FREQUENCY PERFORATION GENERATOR, MODELS RFP-100-115 AND RFP-100-230 Baylis Medical Co., Inc. GEI Class II 2002-02-12
K014048 CLINICON UNIVERSAL WAVEGUIDE HANDPIECE AND FIBER TIPS Clinicon Corp. GEX Class II 2002-02-11
K013749 ENDOANCHOR AND OPENANCHOR Ethicon Endo-Surgery, Inc. GDW Class II 2002-02-11
K013748 CANDELA SCLERO LONG PULSE LASER (AKA VBEAM) Candela Corp. GEX Class II 2002-02-11
K013864 MODIFICATION TO EPI-STAR SURGICAL LASER SYSTEM, M0DEL DS-60 Nidek, Inc. GEX Class II 2002-02-08
K013732 GELZONE Implantech Associates, Inc. MDA Class I 2002-02-07
K020107 SMARTEPIL Cynosure, Inc. GEX Class II 2002-02-07
K013914 POWDERFREE LATEX SURGEON'S GLOVES Kanam Latex Industries Pvt. , Ltd. KGO Class I 2002-02-06
K013730 ARIEL RADIO FREQUENCY (RF) ELECTROSURGICAL CONTROL MODULE AND ACCESSORIES Novasys Medical, Inc. GEI Class II 2002-02-06
K013668 BERCHTOLD ELEKTROTOM 106 HITT Berchtold Corp. GEI Class II 2002-02-04
K012676 REPROCESSED USED, DISPOSABLE BLADES, BURS, BITS AND TAPS Adven Medical HWE Class I 2002-02-04
K012694 REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS Adven Medical HWE Class I 2002-02-04
K012314 DYONICS ELECTROBLADE RESECTOR Smith & Nephew, Inc. GEI Class II 2002-02-01
K013511 XENALIGHT MODELS # AX9125 (100-120V~); # AX9225 (220-240V~) Aculux, Inc. FSW Class II 2002-02-01
K013622 NUCLEOTOMY INTRADISCAL CATHETER Oratec Interventions, Inc. GEI Class II 2002-01-31
K020077 MODIFICATION TO AUGUSTINE MEDICAL WOUND CARE SYSTEM, MODEL 68XXX Augustine Medical, Inc. MSA Class I 2002-01-31
K013639 THERMAGE THERMACOOL TC SYSTEM Thermage, Inc. GEI Class II 2002-01-29
K013641 SENORX BIOPSY DEVICE, DRIVER, CONTROL MODULE, INCLUDING ACCESSORIES (POWER CORD,CONNECTOR CORDS AND FOOTSWITCH), VACUUMS Senorx, Inc. GEI Class II 2002-01-29
K011950 SEEDNET, MODEL FP6T5, FP5T5, FP5T3 Galil Medical , Ltd. GEH Class II 2002-01-29
K013585 MEDIPORT 2000 MOBILE Servox Medizintechnik GmbH BTA Class II 2002-01-28
K014021 SHARPOINT COATED, FAST ABSORBING POLYGLYCOLIC ACID SYNTHETIC SUTURE, UNDYED Surgical Specialties Corp GAM Class II 2002-01-28
K013392 CARDIOBLATE SURGICAL ABLATION PEN, MODEL 60811C; CARDIOBLATE SURGICAL ABLATION GENERATOR, MODEL 60880 Medtronic Vascular OCL Class II 2002-01-25
K011074 CRYOCARE SURGICAL SYSTEM Endocare, Inc. GEH Class II 2002-01-25
K013664 COALESCENT SURGICAL U-CLIP Coalescent Surgical NCA Class II 2002-01-24

16,323 clearances in the General, Plastic Surgery panel. Data: openFDA.