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
1998-07-29

Clearances · page 90 of 164

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K980389 MEGABEAM REUSABLE FIBER OPTIC HANDPIECE AND NEEDLES Ceram Optec, Inc. GEX Class II 1998-07-29
K981631 INFLUENCE CLIP SYSTEM Influence, Inc. FZP Class II 1998-07-28
K982184 WALLSTENT ENDOPROSTHESIS Boston Scientific Scimed, Inc. JCT Class II 1998-07-21
K980517 EPILASER NORMAL MODE RUBY LASER Palomar Medical Products, Inc. GEX Class II 1998-07-21
K981438 DORNIER MEDILAS E Dornier Surgical Products, Inc. GEX Class II 1998-07-20
K981614 NON-STERILE HOLSTER, STERILE HOLSTER MODEL ESH1-NS, ESH1, ES PENCIL W/ HOLSTER, ES SMOKE & FLUID PENCIL W/ HOLSTER MODEL Aaron Medical Industries GEI Class II 1998-07-17
K980670 CMS BLIZZARD 700 SERIES MODELS 710, 711, 712, 720, 721 AND 722 Cryomedical Sciences, Inc. GEH Class II 1998-07-17
K972575 800 SERIES SURGICAL LASER SYSTEM ORION SERIES SURGICAL LASER SYSTEM ANGLED DELIVERY DEVICES Laserscope GEX Class II 1998-07-17
K970069 DUAL HOOK FIBEROPTIC DELIVERY SYSTEM Ihd, Inc. GEX Class II 1998-07-17
K981672 RADIOTHERAPEUTICS RF-2000 RADIOFREQUENCY GENERATOR Radiotherapeutics Corp. GEI Class II 1998-07-17
K980668 CMS BLIZZARD 700 SERIES MODELS 730, 740,750,760,770,780 & 790 Cryomedical Sciences, Inc. GEH Class II 1998-07-17
K981718 DORNIER MEDILAS H Dornier Surgical Products, Inc. GEX Class II 1998-07-17
K981602 DEVILBISS MODEL 6305D HEAVY DUTY AC ASPIRATOR Sunrise Medical Hhg, Inc. BTA Class II 1998-07-17
K974586 AURORA DIODE LASER SYSTEM Premier Laser Systems, Inc. GEX Class II 1998-07-15
K981582 SURGILON, DERMALON, & OPHTHALON Davis & Geck, Inc. GAR Class II 1998-07-13
K981351 CANDELA GENTLELASE GL DERMATOLOGICAL LASER Candela Corp. GEX Class II 1998-07-13
K980771 LYSONIX SUCTION LIPOPLASTY SYSTEM Lysonix, Inc. QPB Class II 1998-07-13
K981361 POWERSTAR BIPOLAR SCISSORS ETHICON, Inc. GEI Class II 1998-07-13
K981393 MICROCOOL SURGICAL GOWN Kimberly-Clark Corp. FYA Class II 1998-07-10
K981818 CONVERTORS TRILAMINATE DRAPES Allegiance Healthcare Corp. KKX Class II 1998-07-10
K980538 LASER LANCET LB100 Transmedica Intl., Inc. GEX Class II 1998-07-09
K981850 SILIMED CHIN IMPLANTS Silimed, LLC FWP Class II 1998-07-09
K981469 CERMAX300 LIGHTSOURCE Cuda Products Co. FSS Class II 1998-07-09
K981350 ALEXIS ALEXANDRITE LASER SYSTEM AND ACCESSORIES Xintec Corporation GEX Class II 1998-07-09
K981579 ENDOPOUCH PRO SPECIMEN RETRIEVAL BAG ETHICON, Inc. MDM Class I 1998-07-09
K981310 MAGNATEK C-300 Magna Advanced Technologies, Inc. GEI Class II 1998-07-09
K981527 MENTOR PATHWAY INTRODUCER/DILATOR Mentor Corp. QPB Class II 1998-07-09
K981835 SILIMED MALAR IMPLANT Silimed, LLC LZK Class II 1998-07-09
K980501 SKINTONER SYSTEM Fuller Research Corp. GEX Class II 1998-07-08
K980177 SUGITRON MODEL: IEC Ellman Intl., Inc. GEI Class II 1998-07-07
K981321 BIPOLAR FORCEPS SET (MODULAR) Richard Wolf Medical Instruments Corp. GEI Class II 1998-07-07
K981322 CUTALON NYLON POLYAMIDE SURGICAL SUTURE Genzyme Surgical Product (Genzyme Biosurgery) GAR Class II 1998-07-07
K974025 ANSPACH SHIELDED ATTACHMENT The Anspach Effort, Inc. GFF Class I 1998-07-06
K980913 CRYO-HIT MODEL NUMBERS EP3T3, EP5T2, EP5T5, EP7T5, EP8T5 Galil Medical , Ltd. GEI Class II 1998-07-01
K981215 PSI-TEC LIPOSUCTION ASPIRATOR Byron Medical QPB Class II 1998-07-01
K981717 STRYKER KNIFELIGHT, STRYKER ILLUMINATED RETRACTOR Stryker Instruments FTD Class II 1998-06-30
K981172 LIPOPLASTY/ LIPOSUCTION ASPIRATION AND TUMESCENT INFUSION CANNULAE AND NEEDLES Byron Medical QPB Class II 1998-06-30
K980170 SURGITRON Ellman Intl., Inc. GEI Class II 1998-06-29
K981219 OSCAR BIPOLAR SCISSORS AND OSCAR BIPOLAR REUSABLE CARTRIDGES Enable Medical Corp. GEI Class II 1998-06-29
K981149 LASETTE LASER SKIN PERFORATOR Cell Robotics, Inc. GEX Class II 1998-06-29
K980753 CHROMOSCAN SCANNING SYSTEM Mehl/Biophile Intl., Inc. GEX Class II 1998-06-29
K980915 VALLEYLAB OPTIMUMM SMOKE EVACUATOR SYSTEM Valleylab, Inc. FYD Class II 1998-06-29
K981833 SILIMED NASAL L SHAPED IMPLANT Silimed, LLC FZE Class II 1998-06-26
K981126 CERALAS G FREQUENCY DOUBLED ND: YAG LASER SYSTEMS, CERALAS G3 Ceram Optec, Inc. GEX Class II 1998-06-25
K981935 POLYSORB SUTURE United States Surgical, A Division of Tyco Healthc GAM Class II 1998-06-25
K981902 SPENCO SILICONE GEL SHEET Spenco Medical Corp. MDA Class I 1998-06-25
K974593 SEMKIN INSULATED BIPOLAR FORCEP Titan Mfg., Inc. HTD Class I 1998-06-24
K974594 SEMKIN BIPOLAR FORCEP Titan Mfg., Inc. HTD Class I 1998-06-24
K974595 CUSHING BAYONET, INSULATED BIPOLAR FORCEP Titan Mfg., Inc. HTD Class I 1998-06-24
K974735 STANDARD AND EXTENDED BLADE, NEEDLE AND BALL; MODIFIED STANDARD AND EXTENDED BLADE & NEEDLE; STANDARD 45 DEGREE BLADE Aaron Medical Industries JOS Class II 1998-06-24
K981416 MAGNATEK ELECTROSURGICAL UNITS MODELS, ESU-10, ESU-15 Magna Advanced Technologies, Inc. GEI Class II 1998-06-24
K981724 O.R.PRO 300 ELECTROSURGICAL GENERATOR MODEL 40001-100 Medtrex, Inc. GEI Class II 1998-06-22
K981387 EVANESCE SCAR MANAGEMENT SYSTEM Medical Scientific, Inc. MDA Class I 1998-06-10
K974641 FUTURELASE 3000/3002 ERBIUM LASER SYSTEM Buckman Co., Inc. GEX Class II 1998-06-08
K981447 DIO-LIGHT 60 LASER SYSTEM Nidek, Inc. GEX Class II 1998-06-05
K981430 UNION MEDICAL UM-D30 COAGULATOR She Medical, Inc. GEI Class II 1998-06-05
K980929 DERMA PRENE POWDER-FREE SYNTHETIC SURGICAL GLOVES Ansell Perry KGO Class I 1998-06-05
K980838 REUSABLE MEGABEAM FIBER OPTIC DELIVERY SYSTEM Ceram Optec, Inc. GEX Class II 1998-06-02
K981389 DISPOSABLE RE-NEW FORCEPS Microline Pentax, Inc. GEI Class II 1998-05-29
K972849 ISOSAFE EARLOOP PROCEDURE MASK (BLUE, YELLOW) Cypress Medical Products, Ltd. FXX Class II 1998-05-28
K980763 LYSONIX LIPOPLASTY ACCESS PORT Lysonix, Inc. QPB Class II 1998-05-28
K980431 SURGISIS Cook Biotech, Inc. FTM Class II 1998-05-28
K981061 INTRAVASCULAR RETRIEVAL DEVICE Med Institute, Inc. GCC Class I 1998-05-26
K980739 HISTOFREEZER/ 17% SALICYLIC ACID-VERRUCA PLANTARIS OraSure Technologies, Inc. GEH Class II 1998-05-26
K980710 SCHWARTZ ELECTRO-OPTICS, INC. CRYSTALASE 755 DP ALEXANDRITE LASER SYSTEM Schwartz Electro-Optics, Inc. GEX Class II 1998-05-22
K980685 MODIFIED VERSAPULSE SELECT HO:YAG AND HO:YAG/ND:YAG LASERS Lumenis, Inc. GEX Class II 1998-05-20
K980880 SENSI-DERM LATEX SURGICAL GLOVES (POWDERED) Ansell Perry KGO Class I 1998-05-20
K980563 SKAR-KARE SHEET Life Medical Sciences, Inc. MDA Class I 1998-05-20
K974540 SIS HERNIA REPAIR DEVICE Sentron Medical, Inc. FTL Class II 1998-05-20
K981188 ELECTROSURGICAL CAUTERY PROBES Microline Pentax, Inc. GEI Class II 1998-05-20
K974536 PHOTODERM HR SYSTEM Esc Medical Systems , Ltd. GEX Class II 1998-05-20
K980610 DEXON RAPID (DEXON R) Davis & Geck, Inc. GAM Class II 1998-05-18
K980210 VARIOUS SURGICAL OR PATIENT DRAPES Gel-Lite, LLC KKX Class II 1998-05-15
K981073 MEDCOM GOWN PACK, MEDCOM DRAPE PACK & MEDCOM TOWEL PACK Medcom Laundry Service, Inc. FYA Class II 1998-05-15
K981239 DEROYAL INDUSTRIES DISPOSABLE LAPAROSCOPIC CLIP APPLIER WITH IMPLANTABLE TITANIUM CLIPS Deroyal Surgical FZP Class II 1998-05-14
K971207 SOFTLIGHT Q-SWITCHED (ND:YAG) LASER Thermolase Corp. GEX Class II 1998-05-13
K980547 NIDEK PRIMA MODEL GYC-1500/2000 Nidek, Inc. GEX Class II 1998-05-13
K973955 HERNIAMESH SURGICAL MESHES Herniamesh FTL Class II 1998-05-11
K974038 THE ASPIRATOR, 6FT SILICONE TUBING, METAL TUBING ADAPTER, GLASS RESERVOIR, NEOPRENE STOPPER, ANGLED TUBE MOUNTS, FOOT A & A Medical, Inc. JCX Class II 1998-05-11
K980704 SAFIL SYNTHETIC ABSORBABLE SURGICAL SUTURE Aesculap, Inc. GAM Class II 1998-05-11
K980942 REGENT BIOGEL INDICATOR INNER SURGICAL GLOVE London International Group, Inc. KGO Class I 1998-05-11
K981128 SOFSILK SUTURE United States Surgical, A Division of Tyco Healthc GAP Class II 1998-05-11
K980988 AXYA MEDICAL, INC. AUTOMATIC SUTURING AND LIGATING SYSTEM-(ASLS) Axya Medical, Inc. GAB Class I 1998-05-11
K981392 ELITE MARK IV POWDER FREE POLYURETHANE SYNTHETIC SURGICAL GLOVE Ansell Perry KGO Class I 1998-05-11
K980446 SPECTRUM DESIGNS ANTERIOR CHIN IMPLANT Spectrum Designs, Inc. FWP Class II 1998-05-06
K980463 SPECTRUM DESIGNS CURVILINEAR CHIN IMPLANT Spectrum Designs, Inc. FWP Class II 1998-05-06
K980462 SPECTRUM DESIGNS ANATOMICAL CHIN IMPLANT Spectrum Designs, Inc. FWP Class II 1998-05-06
K980445 SPECTRUM DESIGNS CONCAVE BACK CHIN IMPLANT Spectrum Designs, Inc. FWP Class II 1998-05-06
K980444 SPECTRUM DESIGNS BILATERAL GROOVE CHIN IMPLANT Spectrum Designs, Inc. FWP Class II 1998-05-06
K980420 LIGHTSHEER Palomar Medical Products, Inc. GEX Class II 1998-05-04
K980703 PREMILENE NONABSORBABLE POLYPROPYLENE SURGICAL SUTURE Aesculap, Inc. GAW Class II 1998-05-04
K980393 SOPRANO CRYO-THERAPY SYSTEM Gynecare Innovation Center GEI Class II 1998-05-01
K980483 MENTOR SUSPEND SLING Mentor Corp. FTL Class II 1998-04-30
K981081 BRIGHTSTAR Hill-Rom, Inc. FSY Class II 1998-04-29
K980784 SURETOUCH Sahar Technologies, Inc. GEX Class II 1998-04-29
K974674 CYNOSURE PHOTOLIGHT FLASHLAMP SYSTEM Cynosure, Inc. GEX Class II 1998-04-29
K972911 AUTO SUTURE*ENDOSTITCH* II** SUTURE APPLIER United States Surgical, A Division of Tyco Healthc GAT Class II 1998-04-25
K980516 REGENT BIOGEL ORTHOPEDIC SURGICAL GLOVE London International Group, Inc. KGO Class I 1998-04-23
K980361 DERMABLATE ER: YAG LASER SYSTEM Aesculap-Meditec North America GEX Class II 1998-04-21
K972548 SLT CL MD CONTACT LASER SYSTEM Surgical Laser Technologies, Inc. GEX Class II 1998-04-21

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