meddevicedb.com FDA Device Reference

Review Panel

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

Cleared Devices
16,323
Product Codes (page)
34
Latest Decision
2001-10-12

Clearances · page 81 of 164

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K004005 MENTOR ULTRASOUND-ASSISTED TISSUE REMOVAL SYSTEM (CURRENT), MENTOR CONTOUR GENESIS SYSTEM (PROPOSED) Mentor Corp. QPB Class II 2001-10-12
K013043 CANDELA CLEARBEAM PULSED DYE LASER Candela Corp. GEX Class II 2001-10-11
K012315 LEVEEN ELECTRODE Radiotherapeutics Corp. GEI Class II 2001-10-11
K003811 CRYOCARE SURGICAL SYSTEM Endocare, Inc. GEH Class II 2001-10-11
K012807 MODIFICATION TO: COMPEL SURGICAL DRAPES Standard Textile Co., Inc. KKX Class II 2001-10-11
K010528 TITANIUM CEMENT RESTRICTOR MATERIAL PEEK Medtronic Sofamor Danek USA, Inc. JDK Class II 2001-10-10
K011021 LASER 20 Ya-Man, Ltd. GEX Class II 2001-10-09
K010804 MEGABEAM/CERALAS REUSEABLE HANDPIECE AND DISPOSABLE TIPS Biolitec, Inc. GEX Class II 2001-10-04
K013034 MODIFICATION TO: THERMACOOL IIA Thermage, Inc. GEI Class II 2001-10-04
K012127 PULSEMASTER ERBIUM DENTAL LASER SYSTEM American Dental Technologies, Inc. GEX Class II 2001-10-04
K013014 BLOCK CEMENT RESTRICTOR (CR) - TITANIUM Medtronic Sofamor Danek, Inc. JDK Class II 2001-10-04
K010715 AL-40 Ddc Technologies, Inc. GEX Class II 2001-10-04
K012949 URETEX SUP PUBOURETHRAL SLING Sofradim Production OTN Class II 2001-10-04
K012923 ARTHREX FIBERWIRE, USP SIZE 5, MODEL AR-7201 Arthrex, Inc. GAT Class II 2001-10-04
K012986 BIPOLAR IRRIGATION FORCEPS Aesculap, Inc. GEI Class II 2001-10-03
K012982 COOLTOUCH VARIZOOM New Star Lasers, Inc. GEX Class II 2001-10-02
K012479 STERILE NITRILE SURGICAL GLOVES (POWDERED) Smart Glove Corp. Sdn Bhd KGO Class I 2001-09-26
K012004 EASY GUIDE ELECTROSURGICAL ACCESS DEVICE Senorx, Inc. GEI Class II 2001-09-25
K012865 SUPERSTITCH VASCULAR SUTURING DEVICE Sutura, Inc. GAW Class II 2001-09-25
K012984 BREATHABLE IMPERVIOUS GOWNS Allegiance Healthcare Corp. FYA Class II 2001-09-24
K011988 SURGICAL LIGHTSTIC 180, MODEL 180 L, MODEL 180 C Cardiofocus, Inc. OCL Class II 2001-09-20
K012042 KINETIC CANNULA Reliance Medical Corp. QPB Class II 2001-09-20
K012033 MULTIFUNCTION ENDOSCOPIC INSTRUMENT Seedling Enterprises., LLC GEI Class II 2001-09-20
K012124 MERSILK BLACK SILK BRAIDED NON-ABSORBABLE SUTURE, USP Johnson & Johnson Medical (China) , Ltd. GAP Class II 2001-09-19
K012201 PREMICRON NONABSORBABLE PET SURGICAL SUTURE Aesculap, Inc. GAT Class II 2001-09-19
K011943 IMPRO VISE ABSORBABLE CEMENT FLOW RESTRICTOR Kensey Nash Corp. LZN Class II 2001-09-19
K011929 HANDPIECE SHEATH-MODEL #A910 Aaron Medical, Inc. GEI Class II 2001-09-18
K012168 ADVANCE MEDICAL DESIGNS FLUID POUCH Advance Medical Designs, Inc. KKX Class II 2001-09-18
K012067 CLINCARE LATEX SURGEON'S GLOVE Ttk Healthcare , Ltd. KGO Class I 2001-09-17
K011066 STERILE LATEX SURGICAL GLOVES (POWDERED) WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS) Smart Glove Corp. Sdn Bhd KGO Class I 2001-09-11
K010618 PALOMAR DERMALUX PULSED LIGHT SYSTEM Palomar GEX Class II 2001-09-10
K011828 CYNOSURE ACCLAIM DERMATOLOGY LASER Cynosure, Inc. GEX Class II 2001-09-07
K012342 AMS SOFT-TISSUE APPROXIMATION SYSTEM American Medical Systems, Inc. FZP Class II 2001-09-05
K012799 ES-2000 SHAPE SELECT ELECTROSURGICAL SCALPEL Senorx, Inc. GEI Class II 2001-09-04
K012317 COALESCENT SURGICAL U-CLIP Coalescent Surgical FZP Class II 2001-08-31
K011725 OLYMPUS SUCTION PUMP, MODEL KV-5 Keymed (Medical & Industrial Equipment), Ltd. JCX Class II 2001-08-31
K012488 MODIFICATION TO:ENDIUS BIPOLAR SHEATH Endius, Inc. GEI Class II 2001-08-30
K011769 OPUS 10 (WITH TOOTH WHITENING APPLICATION), MODEL 2ND Opusdent , Ltd. GEX Class II 2001-08-30
K011747 PALOMAR LC 100 DIODE LASER Palomar Medical Technologies, Inc. GEX Class II 2001-08-30
K011722 ATRICURE BIPOLAR COAGULATION SYSTEM AtriCure, Inc. GEI Class II 2001-08-30
K011703 LUMENIS VERSAPULSE POWERSUITE HOLMIUM (HO:YAG) AND DUAL WAVELENGTH (HO:YAG/ND:YAG) SURGICAL LASERS AND DELIVERY DEVICES Lumenis GEX Class II 2001-08-29
K002172 POLY-TAPES (VARIOUS SIZES AND WOVEN CONSTRUCTION VARIANTS) Xiros Plc GAT Class II 2001-08-28
K011025 FORTAFLEX SURGICAL MESH Organogenesis, Inc. FTM Class II 2001-08-24
K012362 MODIFICATION TO VASCULAR CLOSURE DEVICE Std Mfg., Inc. GDW Class II 2001-08-23
K011856 RADIOGRAPHIC MARKERS Encore Orthopedics, Inc. NEU Class II 2001-08-22
K011073 CRYOPLAN SYSTEM Cryomedical Sciences, Inc. GEH Class II 2001-08-22
K012129 ORTHO DEVELOPMENT ORION-I EMF SYSTEM Ortho Development Corp. GEI Class II 2001-08-22
K012104 SNOW LOTUS POWDER-FREE LATEX SURGEON'S GLOVES Beijing Reagent Latex Products Co., Ltd. KGO Class I 2001-08-21
K011721 ESTEEM STERILE POLYISOPRENE SURGICAL GLOVES Allegiance Healthcare Corp. KGO Class I 2001-08-14
K011514 INSTRUMENTS FOR ONE TIME USE - DISPOSABLE Kencap , Ltd. KDD Class I 2001-08-13
K002890 INTRALASE 600C LASER KERATOME Intra Lase Corp. GEX Class II 2001-08-09
K011423 INPULSE DENTAL LASER Incisive, LLC GEX Class II 2001-08-07
K011443 THREADED CEMENT RESTRICTOR (CR) TITANIUM Medtronic Sofamor Danek USA, Inc. JDK Class II 2001-08-03
K011382 XTRAC EXCIMER LASER SYSTEM, MODEL AL 7000 Photo Medex, Inc. GEX Class II 2001-08-02
K012135 POWDER FREE BROWN LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) Wrp Asia Pacific Sdn. Bhd. KGO Class I 2001-08-01
K011372 AESCULAP, INC. SAFIL QUICK SYNTHETIC ABSORBABLE SURGICAL SUTURE Aesculap, Inc. GAM Class II 2001-08-01
K012255 MEDTRONIC SOFAMOR DANEK CEMENT RESTRICTOR Medtronic Sofamor Danek, Inc. JDK Class II 2001-08-01
K011251 SPARC SLING SYSTEM American Medical Systems, Inc. OTN Class II 2001-08-01
K011998 METRONIC SOFAMOR DANEK CEMENT RESTRICTOR Medtronic Sofamor Danek, Inc. JDK Class II 2001-07-26
K011207 LASER PERIPHERALS REUSABLE HOLMIUM FIBER Laser Peripherals, LLC GEX Class II 2001-07-24
K011279 ENTEC EVAC PLASMA WAND Arthrocare Corp. GEI Class II 2001-07-19
K011402 BIOPSY SITE MARKER Senorx, Inc. FZP Class II 2001-07-16
K011515 MEDLINE GROUNDING PAD Medline Industries, Inc. JOS Class II 2001-07-13
K011422 SURGICAL DRAPES Advance Medical Designs, Inc. KKX Class II 2001-07-10
K011092 CANDELA SPTL-1E PULSED DYE LASER Candela Corp. GEX Class II 2001-07-09
K011041 WATERLASE, MILLENNIUM Biolase Technology, Inc. GEX Class II 2001-07-03
K010311 LIPOMATIC; LIPOMATIC LIPOSUCTION DEVICE Euromi S.A QPB Class II 2001-06-29
K011375 AESCULAP, INC., MONOSYN SYNTHETIC ABSORBABLE SURGICAL SUTURE Aesculap, Inc. GAM Class II 2001-06-29
K010184 CHESS HAND SURGERY SYSTEM Canica Design, Inc. MDM Class I 2001-06-22
K011789 PROCEDURE MASKS: PM4-301 AND PM4-304 Primeline Medical Products, Inc. FXX Class II 2001-06-22
K011677 MEDLITE Q-SWITCHED ND:YAG LASER REPLACED BY THE MEDLITE C3 Q-SWTICHED ND:YAG LASER Continuum Electro-Optics, Inc. GEX Class II 2001-06-22
K010990 AMS SLING FIXATION SYSTEM American Medical Systems, Inc. GAW Class II 2001-06-22
K011755 STRYKER T4 HYTREL (R) TOGAS Stryker Corp. LYU Class I 2001-06-22
K010928 PROLITE VL PULSED LIGHT SYSTEM Medical Bio Care Sweden AB GEX Class II 2001-06-19
K010927 MODIFICATION TO PROLITE PULSED LIGHT SYSTEM Medical Bio Care Sweden AB GEX Class II 2001-06-19
K011634 ARTHROCARE CONTROLLER, MODEL H2000; ARTHROCARE CABLE, MODEL H0970-02; FOOTSWITCH, MODEL H2000-04; POWERCORD, MODEL H2000 Arthrocare Corp. GEI Class II 2001-06-19
K011040 CRYOCARE CARDIAC SURGICAL SYSTEM Endocare, Inc. OCL Class II 2001-06-15
K010815 NTERO NOMAD SYSTEM Ntero Surgical, Inc. GEI Class II 2001-06-15
K011409 SLT LASERPRO CTH HOLMIUM LASER SYSTEM Surgical Laser Technologies, Inc. GEX Class II 2001-06-14
K011446 BARRIERPLUS POWDER-FREE SYNTHETIC POLYISOPRENE SURGICAL GLOVES Barriermed, Inc. KGO Class I 2001-06-14
K011693 TRUMPF SURGICAL LIGHTS, MODELS 301,501,701,1001 Trumpf Medical Systems, Inc. FSY Class II 2001-06-13
K003190 EN BLOC BIOPSY SYSTEM Neothermia Corp. GEI Class II 2001-06-11
K011601 ARDO SUCTION PUMP MASTER, MODEL 30.00.XX; ARDO SUCTION PUMP SENATOR, MODEL 31.00.XX Ardo Medical AG BTA Class II 2001-06-08
K010724 SOLA 700,SOLA 500, SOLA 300 Drager Medizintechnik GmbH FTD Class II 2001-06-07
K010862 ULTRAFREE MAX STERILE LATEX POWEDER-FREE SURGICAL GLOVES WITH PROTEIN LABELING CLAIM, 50 PER GRAM OR LESS OF TOTAL WATER Allegiance Healthcare Corp. KGO Class I 2001-06-07
K010885 UNI-LASER 470 Medart Corp. GEX Class II 2001-06-07
K010799 COMBOSAFE SURGICAL GOWNS, NON-STERILE (75X REUSABLE) Standard Textile Co., Inc. FYA Class II 2001-06-07
K001442 ESU HANDSWITCHING PENCIL Surgex, Inc. GEI Class II 2001-05-31
K011105 SUTURTEK FASTCLOSE FASCIA CLOSURE DEVICE Qrc Consulting GAL Class II 2001-05-30
K010675 ENSIL FABRIC Gottfried Medical, Inc. MDA Class I 2001-05-30
K010716 VAL LUX 600 SURGICAL LIGHT (PLUS AND RS), MODEL ML600/S: SINGLE LIGHT HEAD, ML600/SS: SINGLE LIGHT HEAD, ML600/1D): DOUB Valmed Corp. FSY Class II 2001-05-30
K011027 FORTAFLEX SURGICAL SLING Organogenesis, Inc. FTM Class II 2001-05-30
K010533 BIOSLING - BIOABSORBABLE POLYMER SLING & SURGICAL MESH Injectx, Inc. FTL Class II 2001-05-24
K003318 PHOTON MULTI-PLATFORM SYSTEM, MODEL Z-12834-X & Z-13175-X Paradigm Medical Industries, Inc. GEX Class II 2001-05-22
K010711 ECOTRACT ADJUSTABLE WOUND PROTECTOR/RETRACTOR Advanced Surgical Concepts (Asc) KKX Class II 2001-05-22
K003978 AFX MICROWAVE GENERATOR, FLEX ABLATION WAND, LYNX ABLATION WAND, MODEL SERIES 1000, P/N 102006, P/N 102007 Afx, Inc. NEY Class II 2001-05-22
K010580 PALOMAR SLP 1000 Palomar Medical Technologies, Inc. GEX Class II 2001-05-22
K010936 MODIFICATION TO SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL W. L. Gore & Associates, Inc. OXD Class II 2001-05-21
K010834 LYRA SERIES SURGICAL LASER SYSTEM & ACCESSORIES Laserscope GEX Class II 2001-05-21
K003446 SYMMETRY AORTIC CLIP SYSTEM St. Jude Medical Cardiovascular Group, Inc. NCA Class II 2001-05-21

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