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
2003-03-20

Clearances · page 76 of 164

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K030411 PROXIMATE PPH HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES, MODEL PPH03 Ethicon Endo-Surgery, Inc. GDW Class II 2003-03-20
K024009 CRYOPROBE H&O Equipments, Nv/Sa GEH Class II 2003-03-20
K023487 HISTOFREEZER WART REMOVAL SYSTEM OR OTHER PROPRIETARY NAME OraSure Technologies, Inc. GEH Class II 2003-03-20
K023237 XYLOS SURGICAL MESH Xylos Corporation FTM Class II 2003-03-18
K023954 ALTUS MEDICAL COOLGLIDE LASER SYSTEMS AND ACCESSORIES Altus Medical, Inc. GEX Class II 2003-03-18
K023694 BIO-MARK RESORBABLE BIOPSY SITE MARKER AND BIO-MARK PERMANENT BIOPSY SITE MARKER Biopsy Sciences, LLC NEU Class II 2003-03-17
K030227 SUTURTEK FASTCLOSE SUTURING DEVICE Suturtek Incorporated GAL Class II 2003-03-17
K024160 NEOSPORIN SCAR SOLUTION Warner-Lambert Co. MDA Class I 2003-03-17
K024275 AUTO SUTURE PREMIUM PLUS CEEA DISPOSABLE STAPLER United States Surgical, A Division of Tyco Healthc GDW Class II 2003-03-14
K024199 IMMIX THIN FILM, MODELS: PSS-004-S, PSS-004-SP, PSS-004-M, PSS-004-MP, PSS-004-L, PSS-004-LP Osteobiologics, Inc. FTL Class II 2003-03-14
K030228 POWDERFREE POLYCHLOROPRENE STERILIZED SURGICAL GLOVES Pt. Medisafe Technologies KGO Class I 2003-03-14
K022923 CANDELA GENTLE YAG LASER SYSTEM Candela Corp. GEX Class II 2003-03-13
K023111 GYRUS PLASMA SKIN RESURFACING SYSTEM Gyrus Medical, Inc. GEI Class II 2003-03-13
K024266 MSI TA ELECTRODES Medsphere International, Inc. GEI Class II 2003-03-12
K024335 CANDELA GENTLELASE FAMILY OF LASER SYSTEMS Candela Corp. GEX Class II 2003-03-12
K024138 HEAT SCISSORS GENERATOR SET AND HEAT SCISSORS HANDPIECE Olympus Optical Co., Ltd. GEI Class II 2003-03-12
K030557 MODIFICATION TO VNUS CLOSURE SYSTEM Vnus Medical Technologies, Inc. GEI Class II 2003-03-11
K024178 VIATORR ENDOPROSTHESIS W. L. Gore & Associates, Inc. JCT Class II 2003-03-07
K030551 ARTHROCARE CONTROLLER (SYSTEM 2000 AND 8000); ARTHROCARE PATIENT CABLE; FOOT CONTROL; POWER CORD; WANDS Arthrocare Corp. GEI Class II 2003-03-07
K030339 CAUTERY TIP CLEANER, MODEL-TC-100 Aspen Surgical Products, Inc. GEI Class II 2003-03-07
K024061 PEREGRINE STRAIGHT LASER PROBE, MODEL PD6000.00 Peregrine Surgical , Ltd. GEX Class II 2003-03-07
K030460 MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX Brennen Medical, Inc. PAG Class II 2003-03-07
K021546 DERMASSIST FLUID RESISTANT SURGICAL MASK WITH WRAPAROUND VISOR Creative Contract (M) Sdn Bhd FXX Class II 2003-03-05
K021533 DERMASSIST PROCEDURE MASK/SURGICAL MASKS (GREEN, BLUE, YELLOW, PINK, WHITE) Creative Contract (M) Sdn Bhd FXX Class II 2003-03-05
K021539 DERMASSIST FLUID RESISTANT SURGICAL MASK (ORANGE) AND PROCEDURE MASK WITH TIE-ON AND WITH EARLOOPS Creative Contract (M) Sdn Bhd FXX Class II 2003-03-05
K030380 TISSUELINK SEALING FORCEPS, MODEL 1 21-202-1 Tissuelink Medical, Inc. GEI Class II 2003-03-03
K024090 NYLON SUTURE Aurolab GAR Class II 2003-02-28
K024091 SILK SUTURES Aurolab GAP Class II 2003-02-28
K023966 DISPOSABLE BI-POLAR CABLE Modern Medical Equipment Mfg., Ltd. GEI Class II 2003-02-27
K030311 HEM-O-LOK XL CLIP Weck FZP Class II 2003-02-26
K022011 V.A.C. ABDOMINAL DRESSING Kinetic Concepts, Inc. FTL Class II 2003-02-26
K030473 SENORX ES-300 Senorx, Inc. GEI Class II 2003-02-26
K024304 MICROSURGICAL BIPOLAR HANDPIECE Neomedix Corp. GEI Class II 2003-02-25
K023456 OXYBOX SYSTEM Oxyfast Corporation KPJ Class II 2003-02-24
K023924 AUTOCON II 200 ELECTROSURGICAL GENERATOR Karl Storz Endoscopy GEI Class II 2003-02-21
K023899 DUAL YELLOW LASER, MODEL D10B Norseld Pty., Ltd. GEX Class II 2003-02-20
K022709 MEDLITE Q-SWITHCED LASER Continuum Electro-Optics, Inc. GEX Class II 2003-02-20
K024008 SMALL BARD VENTRALEX PATCH C.R. Bard, Inc. FTL Class II 2003-02-20
K023882 THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM Implex Corp. EZX Class II 2003-02-19
K030338 ICLEAR PHOTOTHERAPY SYSTEM, MODEL FGCM0002 Curelight, Ltd. GEX Class II 2003-02-12
K022532 TISSUELINK BIPOLAR FLOATING BALL DEVICE Tissuelink Medical, Inc. GEI Class II 2003-02-12
K023419 TRILAMINATE DRAPES/TIBURON Allegiance Healthcare Corp. KKX Class II 2003-02-11
K023912 POWDER FREE LATEX SURGEON'S GLOVES CONTAINS 50 MEGM OR LESS OF TOTAL WATER EXTRACTABLE PER GRAM Sanrea Healthcare Private Limited KGO Class I 2003-02-11
K021852 OLYMPUS PSD-20 ELECTROSURGICAL SYSTEM & ITS ASSOCIATED ACCESSORIES Olympus Optical Co., Ltd. GEI Class II 2003-02-11
K024064 POLARIS DS Syneron Medical, Ltd. GEX Class II 2003-02-10
K022856 BOVIE IDS-300 HIGH FREQUENCY ELECTROSURGICAL GENERATOR Aaron Medical Industries GEI Class II 2003-02-10
K030123 BIOARC SP SLING KIT American Medical Systems, Inc. OTN Class II 2003-02-06
K023540 SNAP KOVER, MODEL 01-2020; SNAP KAPS, MODEL 03-KP09 Valumed MMP Class II 2003-02-04
K023725 HEMORRHAGE OCCLUDER PIN (HOP), MODEL 337-247 Marina Medical Instruments, Inc. GDW Class II 2003-02-03
K023729 SIASCOPE II Astron Clinica Limited PSN Class II 2003-02-03
K030142 THERMACOOL TC SYSTEM Thermage, Inc. GEI Class II 2003-02-03
K030108 ARTHROCARE ENT COBLATOR SURGERY SYSTEM Arthrocare Corp. GEI Class II 2003-02-03
K023688 LEMAITRE VASCULAR DISPOSABLE VEIN STRIPPER LeMaitre Vascular, Inc. GAF Class I 2003-01-30
K023704 KSEA SCB ACC CONTROL KARL STORZ Endoscopy-America, Inc. FTA Class II 2003-01-30
K022008 CARDIMA ABLATION SYSTEM Cardima, Inc. OCL Class II 2003-01-29
K022807 MELADINE NATURAL MELANIN ENHANCER, PRODUCT NUMBER CT81602AA Creative Technologies, Inc. GEX Class II 2003-01-29
K030049 MODIFICATION TO RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 30086 Rubicor Medical, Inc. GEI Class II 2003-01-29
K030031 SOFT TISSUE ANCHORING WASHERS Accu-Speed, Incorporated KGS Class I 2003-01-28
K023624 SLT VENOUS FIBER DELIVERY SYSTEMS, MODEL: 0041-6772/0041-6781/0041-6752/0041-6761/0041-6912/0041-6921 Surgical Laser Technologies, Inc. GEX Class II 2003-01-27
K023967 PALOMAR Q-YAG ND:YAG LASER SYSTEM Palomar Medical Technologies, Inc. GEX Class II 2003-01-27
K022341 TERABYTE 2000 HAIR REMOVER Terabyte Co. GEX Class II 2003-01-27
K022951 CANDELA GENTLE YAG LASER SYSTEM, VARIABLE PULSE YAG Candela Corp. GEX Class II 2003-01-27
K023678 DIMISIL SCAR GEL Aesthetic and Reconstructive Technologies, Inc. MDA Class I 2003-01-23
K022884 CANDELA SMOOTHBEAM LASER SYSTEM Candela Corp. GEX Class II 2003-01-22
K024366 COALESCENT SURGICAL U-CLIP AND ACCESSORIES Coalescent Surgical FZP Class II 2003-01-17
K030028 CPC BY SORING GMBH Soring GmbH Medizintechnik GEI Class II 2003-01-17
K023813 BIPOLAR FORCEPS Richard Wolf Medical Instruments Corp. GEI Class II 2003-01-17
K024020 THERALIGHT UV120-2 UVA/UVB PHOTOTHERAPY SYSTEM Theralight, Inc. FTC Class II 2003-01-17
K023710 VISORB SWIFT Cp Medical GAM Class II 2003-01-17
K023515 PRE-POWDERED LATEX SURGEON'S GLOVES Sanrea Healthcare Private Limited KGO Class I 2003-01-16
K023482 AURA 20 BIPOLAR ELECTROSURGICAL COAGULATOR, MODEL 26-2500 Kirwan Surgical Products, Inc. GEI Class II 2003-01-15
K021992 DHS DISPOSABLE HOOD SYSTEM Biomet, Inc. FYA Class II 2003-01-14
K023464 VIRIDIS TWIN OPHTHALMIC PHOTOCOAGULATOR Quantel Medical GEX Class II 2003-01-13
K024047 ERBE VIO APC WITH ACCESSORIES Erbe USA, Inc. GEI Class II 2003-01-08
K024059 MBC SERIES Soring GmbH Medizintechnik GEI Class II 2003-01-08
K021222 LAD, MODEL LAD-01 Norwood Abbey , Ltd. GEX Class II 2003-01-08
K024088 CERALAS D 980 LASER SYSTEM WITH ENDO LASER VEIN SYSTEM KIT, MODEL: D15 AND D25 Biolitec, Inc. GEX Class II 2003-01-02
K022466 PROFILE 1320 LASER SYSTEM Sciton, Inc GEX Class II 2002-12-31
K024130 POWDER FREE POLYMER COATED GREEN NEOPRENE SURGICAL GLOVES, STERILE Wrp Asia Pacific Sdn. Bhd. KGO Class I 2002-12-30
K023372 NON-BIOABSORBABLE STAPLE Onux Medical, Inc. NJU Class II 2002-12-27
K023962 NEW STAR LASERS, INC. DOVE ND: YAG LASER SYSTEM, MODEL: NS-160 New Star Lasers, Inc. GEX Class II 2002-12-24
K023193 CANDELA GENTLE YAG LASER SYSTEM Candela Corp. GEX Class II 2002-12-20
K022607 SPECTRAPULSE Primary Technology, LLC GEX Class II 2002-12-20
K021500 VACUUM ASSISTED CLOSURE Kinetic Concepts, Inc. OMP Class II 2002-12-20
K023280 OLYMPUS PSD-20 ELECTROSURGICAL SYSTEM AND ITS ASSOCIATED ACCESSORIES Olympus Optical Co., Ltd. GEI Class II 2002-12-19
K023450 BIOPSY SITE TISSUE MARKER DEVICE Promex, Inc. NEU Class II 2002-12-19
K022715 COATED VICRYL PLUS ANTIMICROBIAL (POLYGLACTIN 910) SUTURE ETHICON, Inc. GAM Class II 2002-12-19
K023411 STEELEX STERNUM SET Aesculap, Inc. GAQ Class II 2002-12-19
K023125 COALESCENT U-CLIP- AND ACCESSORIES Coalescent Surgical NJU Class II 2002-12-18
K023173 ANDREWS INTRODUCER, MODEL ASI01 Andrews Surgical Innovations, Ltd. MDM Class I 2002-12-18
K023986 ARTHREX OPES ELECTRODES AND ACCESSORIES Arthrex, Inc. GEI Class II 2002-12-17
K022028 VX-400 TOPICAL HYPERBARIC OXYGEN CHAMBER Vascular One, Inc. KPJ Class II 2002-12-17
K023081 PROLITE / PLASMALITE MPX PULSED LIGHT SYSTEM (PERMANENT HAIR REDUCTION) Medical Bio Care Sweden AB GEX Class II 2002-12-16
K023328 REINFORCED ABSORBABLE SYNTHETIC SURGICAL MESH Center For Biomaterials and Advanced Technologies FTL Class II 2002-12-12
K023886 ERBE VIO ESU WITH ACCESSORIES, MODEL VIO 300 D Erbe USA, Inc. GEI Class II 2002-12-12
K023041 W.O.M. LASER U100 W.O.M. World of Medicine AG GEX Class II 2002-12-11
K023811 MODIFICATION TO VIABAHN ENDOPROSTHESIS W. L. Gore & Associates, Inc. JCT Class II 2002-12-10
K023276 AMSINO TRACHEOSTOMY CARE TRAY Amsino International, Inc. LRO Class II 2002-12-09
K022313 SURGASSIST RIGHT ANGLE LINEAR CUTTER DLU 30MM, 45MM & 60MM - VASCULAR WITH RELOADS, MODELS RALC30V, RALC45V & RALC60V Power Medical Interventions, Inc. GDW Class II 2002-12-09
K023846 MR COMPATIBLE RITA MODEL 90 ELECTOSURGICAL ACCESSORY Rita Medical Systems GEI Class II 2002-12-06

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