meddevicedb.com FDA Device Reference

Review Panel

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

Cleared Devices
16,323
Product Codes (page)
32
Latest Decision
1994-12-13

Clearances · page 104 of 164

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K945893 DISPOSABLE & REUSABLE MONOPOLAR ELECTROSURIGICAL ELECTRODE Boston Surgical Products, Inc. GEI Class II 1994-12-13
K945805 WELLS JOHNSON WECO MONOPOLAR/FRAZIER SUCTION PROBE Wells Johnson Co. GEI Class II 1994-12-13
K942729 LIHTAN 4100 KRYPTON Lihtan Technologies, Inc. GEX Class II 1994-12-13
K944578 BIPOLAR CORD Boston Surgical Products, Inc. GEI Class II 1994-12-08
K945587 CANDELA ELLIPTICAL SPOT HANDPIECE Candela Laser Corp. GEX Class II 1994-12-08
K944642 ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESSORIES Boston Surgical Products, Inc. GEI Class II 1994-12-08
K944634 ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESSORIES Boston Surgical Products, Inc. GEI Class II 1994-12-08
K945377 TRELEX NATURAL(R) MESH Meadox Medicals, Div. Boston Scientific Corp. FTL Class II 1994-12-08
K945717 ELECTROSURGICAL ENDOSCOPIC CORD Boston Surgical Products, Inc. GEI Class II 1994-12-08
K940173 CANDELA Q-SWITCHED ALEXANDRITE LASER Candela Laser Corp. GEX Class II 1994-12-07
K943221 SURGIBOND Sutures , Ltd. GAT Class II 1994-12-05
K943627 SURGISILK Sutures , Ltd. GAP Class II 1994-12-05
K943220 SUTULENE Sutures , Ltd. GAT Class II 1994-12-05
K943223 SURGIDEK B Sutures , Ltd. GAR Class II 1994-12-05
K943217 PLAIN CATGUT Sutures , Ltd. GAL Class II 1994-12-05
K944363 MODEL PBD ESU PENCIL Coral Medical, Inc. GEI Class II 1994-12-05
K945334 CHERRY PIT DISSECTOR Lorrex Health Products GDY Class I 1994-12-05
K942823 MAHE INSTRUMENTS Mahe Intl., Inc. DWG Class II 1994-12-05
K943216 SURGIDEK Sutures , Ltd. GAR Class II 1994-12-05
K943527 MEGABEAM LATERAL FIRE Ceram Optec, Inc. GEX Class II 1994-12-05
K943218 CHROMIC CATGUT Sutures , Ltd. GAL Class II 1994-12-05
K944119 SURE-FLO IRRIGATION Y TUBING SET O.R. Resources, Inc. JCX Class II 1994-12-05
K945336 PEANUT DISSECTOR Lorrex Health Products GDY Class I 1994-12-05
K943222 SURGIDEK S Sutures , Ltd. GAR Class II 1994-12-05
K945332 ROSEBUD DISSECTOR Lorrex Health Products GDY Class I 1994-12-05
K931445 KTP/532, KTP/YAG AND KTP/YAG XP Laser Surgical Systems GEX Class II 1994-12-02
K943543 MEDICAL OPTICS CO2 SURGICAL LASER SYSTEMS Medical Options, Inc. GEX Class II 1994-12-02
K944244 MODEL E278OR-ASP SERIES RETRACTABLE Valleylab, Inc. GEI Class II 1994-11-30
K944790 FLEXIBLE LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER Applied Medical Resources GBZ Class I 1994-11-29
K945054 ENDOCARE PROLASE I ADVANCED LASER DELIVERY SYSTEM Cytocare, Inc. GEX Class II 1994-11-28
K943809 MONOGARD FACE SHIELD White Knight Healthcare LYU Class I 1994-11-28
K942339 SKIN NEUVEAU SCAR TREATMENT Puritas Health Care, Inc. MDA Class I 1994-11-28
K944204 LATERALASE, MODIFIED Trimedyne, Inc. GEX Class II 1994-11-28
K945430 DERMAVBLADE(TM) Hasting'S Biomedical Corp. MDM Class I 1994-11-28
K944198 SURGICAL MICROSCOPE DRAPE Hydro-Med Products, Inc. MMP Class II 1994-11-27
K945124 BREAST LESION LOCALIZATION NEEDLE Promex, Inc. GDF Class I 1994-11-22
K944025 SURGICAL INSTRUMENT TRAY Riley Medical, Inc. FSM Class I 1994-11-22
K945415 'LIL MAC ACCESSORY CLAMP(TM) D.L. Nelson and Assoc., Inc. FWZ Class I 1994-11-22
K925610 FLEXIBLE HYDROXYLAPATITE/SILICONE SOFT CHIN IMPLAN Microtek Medical, Inc. FWP Class II 1994-11-18
K942080 SENSATEC ENDOSCOPIC INSTRUMENTS Linvatec Corp. GEI Class II 1994-11-17
K942710 DISPOSABLE BIPOLAR COAGULATING FORCEPS Boston Surgical Products, Inc. GEI Class II 1994-11-17
K944948 FREE-LANCE F.F.F. Enterprises, Inc. FMK Class II 1994-11-17
K940886 ANNELID Kinetic Concepts, Inc. JCX Class II 1994-11-17
K931500 THE PERMARIDGE MATRIX CHIN Applied Biomaterial Technologies FWP Class II 1994-11-17
K944030 DESENTECH PLUME-EVAC SMOKE EVACUATION SYSTEM Desentech, Inc. GEI Class II 1994-11-16
K940276 FILTER, DIFFUSER Anspach Mfg., Inc. HSZ Class I 1994-11-16
K945380 KARL STORZ MONOPOLAR HIGH FREQUENCY CORDS KARL STORZ Endoscopy-America, Inc. GEI Class II 1994-11-16
K945160 PARACENTESIS NEEDLES/CANNULAS Tri-Med Specialties, Inc. LRO Class II 1994-11-14
K941285 ARTHREX GRAFT HARVESTING KIT Arthrex, Inc. KIJ Class I 1994-11-14
K945109 MONOJECT BONE MARROW BIOPSY TRAYS Sherwood Medical Co. GAA Class I 1994-11-14
K942077 BI-TEC ENDOSCOPIC BIPOLAR INSTRUMENTS Linvatec Corp. GEI Class II 1994-11-14
K942868 ACUTOME 2000 COLOR-CORRECTED LAPAROSCOPIC C02 LASER COUPLER AND SLEEVES Reliant Laser Corp. GEX Class II 1994-11-14
K942695 TRI BLOCK POLUMER GEL SHEETING Silipos, Inc. MDA Class I 1994-11-10
K943949 POLYVIOLENE SURGICL SUTURE Look, Inc. GAT Class II 1994-11-10
K944817 NEUTRALECT ADULT STANDARD, RETURN (REM), PAEDIATRIC STANDARD, RETURN (REM) Msb , Ltd. GEI Class II 1994-11-09
K941193 EAST WEST INSTRUMENTS East West Instruments, Inc. MDM Class I 1994-11-09
K944153 ECLIPSE 3200 Cardiogenes GEX Class II 1994-11-09
K945299 DISPOSABLE & REUSABLE CHUCK HANDLE Boston Surgical Products, Inc. GEI Class II 1994-11-09
K945260 E3590, SMOKE EVACUATION ATTCHMENT FOR ELECTROSURGICAL PENCILS Valleylab, Inc. GEI Class II 1994-11-09
K943875 VILLALTA RETRACTOR Hct, Inc. GAD Class I 1994-11-09
K944630 MODEL 230-SAS LASER DELIVERY PROBE Mnlase, Inc. GEX Class II 1994-11-09
K944413 ACM PTFE SURGICAL MESH American Custom Medical, Inc. FTL Class II 1994-11-09
K944346 LASERSONICS RADIANCE DIODE LASER SYSTEMS AND ACCESSORIES Heraeus Surgical, Inc. GEX Class II 1994-11-08
K944818 COOK ASPIRATION/IRRIGATION UNIT Cook Urological, Inc. BTA Class II 1994-11-08
K944977 COAXIAL ENDOSTAT Laserscope GEX Class II 1994-11-08
K921995 CANDELA H:ERB LASER Candela Laser Corp. GEX Class II 1994-11-07
K931267 CONVERTORS ISO BAC DRAPE MATERIAL Baxter Healthcare Corp KKX Class II 1994-11-07
K933101 THE OSTEOMED B POWER SYSTEM AND ACCESSORIES Osteomed Corp. KIJ Class I 1994-11-07
K944552 PILLING WECK M-20 DISPOSABLE AUTOMATIC HEMOCLIP Pilling Weck, Inc. FZP Class II 1994-11-07
K934861 HARD TISSUE REPLACEMENT (HTR) GRANULAR Poly-Medics,Inc. KKY Class II 1994-11-04
K942425 PROXIDERM (TENTATIVE) Progressive Surgical Products, Inc. MKY Class I 1994-11-04
K944166 DORSAL COLUMELLA IMPLANT Spectrum Designs, Inc. LZK Class II 1994-11-04
K944165 SILHOUETTE MALAR IMPLANT Spectrum Designs, Inc. LZK Class II 1994-11-04
K944164 MENISCUS CHIN IMPLANT Spectrum Designs, Inc. LZK Class II 1994-11-04
K944942 BREAST LESION LOCALIZATION NEEDLE Promedical , Ltd. GDF Class I 1994-11-04
K944625 MODEL 210-AC ASPIRATING ENDOPHOTOCOAGULATOR LASER Mnlase, Inc. GEX Class II 1994-11-03
K941559 PARADERM -585M DERMATOLOGICAL LASER Paradigm Lasers, Inc. GEX Class II 1994-11-03
K944471 STRAIGHT ENDOPHOTOCOAGULATOR LASER PROBE Mnlase, Inc. GEX Class II 1994-11-03
K942548 JENNINGS JAVELIN Jfi Endineering, Inc. FMK Class II 1994-11-03
K944628 MODEL 220-SS LASER DELIVERY PROBE Mnlase, Inc. GEX Class II 1994-11-03
K944470 CURVED ENDOPHOTOCOAGULATOR LASER PROBE Mnlase, Inc. GEX Class II 1994-11-03
K944629 MODEL 230-SAC LASER DELIVERY PROBE Mnlase, Inc. GEX Class II 1994-11-03
K944626 MODEL 210-AS ASPIRATING ENDOPHOTOCOAGULATOR LASER Mnlase, Inc. GEX Class II 1994-11-03
K945030 SURGI-LINK LAPAROSCOPIC ELECTRODES Unimed Surgical Products, Inc. GEI Class II 1994-11-03
K944627 MODEL 220-SC CURVED ENDOPHOTOCOAGULATOR LASER Mnlase, Inc. GEX Class II 1994-11-03
K944823 KARL STORZ INSULATED DISSECTING CANNULAE, CANNULAE, SUCTION TUBES, INSERT TUBES Karl Storz Endoskop GmbH GEI Class II 1994-11-02
K940720 BUSSE ISOLATION AND PROCEDURAL MASKS Busse Hospital Disposables, Inc. FXX Class II 1994-11-02
K942821 MAHE INSTRUMENTS Mahe-Medizintechnik GEI Class II 1994-11-02
K944545 BODY FLUIDS BARRIER KIT Ani Safety, Inc. FXX Class II 1994-11-02
K944796 KARL STORZ MONOPOLAR COAGULATING, NEDLE ELECTRODES KARL STORZ Endoscopy-America, Inc. GEI Class II 1994-11-02
K944898 SURGI-LINK BIPOLAR ELECTRODES Unimed Surgical Products, Inc. GEI Class II 1994-11-01
K944282 LASER DELIVERY PROBE Mnlase, Inc. GEX Class II 1994-11-01
K933057 MULTILITE ERBIUM:YAG SURGICAL LASER SYSTEM Continuum Electro-Optics, Inc. GEX Class II 1994-11-01
K945143 DENTAL LASER FIBER SYSTEM Incisive Technologies, Inc. GEX Class II 1994-11-01
K944631 MODEL 120-SC LASER DELIVERY PROBE Mnlase, Inc. GEX Class II 1994-11-01
K944622 MODEL 110-AS ASPIRATING ENDOPHOTOCOAGULATOR LASER Mnlase, Inc. GEX Class II 1994-11-01
K944621 MODEL 110-AC ASPIRATING ENDOPHOTOCOAGULATOR LASER Mnlase, Inc. GEX Class II 1994-11-01
K944632 MODEL 120-SS LASER DELIVERY PROBE Mnlase, Inc. GEX Class II 1994-11-01
K944151 OPTICAL FIBER FOR ENT APPLICATIONS Cardiogenes GEX Class II 1994-11-01
K944623 MODEL 130-SAS ASPIRATING ENDOPHOTOCOAGULATOR LASER Mnlase, Inc. GEX Class II 1994-11-01

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