FDA Product Code
FDA Product Code GEI — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4400
510(k) Clearances — 2,319 records · page 12 of 24
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K050361 | MODIFICATION TO CONCERTO BIPOLAR NEEDLE ELECTRODE | Boston Scientific Corp | 2005-03-14 | Special | PDF ↗ |
| K050364 | MALIS 2000 BIPOLAR ELECTROSURGICAL SYSTEM | Valley Forge Scientific Corp. | 2005-03-09 | Special | PDF ↗ |
| K041999 | GYRUS PLASMA SKIN RESURFACING SYSTEM | Gyrus Medical, Inc. | 2005-03-02 | Traditional | PDF ↗ |
| K050223 | VIVAWAVE MICROWAVE ABLATION SYSTEM, COAXIAL INTRODUCER | Vivant Medical, Inc. | 2005-02-24 | Special | PDF ↗ |
| K042274 | PSD-60/ENDOPLASMA | Olympus Shirakawa Co., Ltd. | 2005-02-22 | Traditional | PDF ↗ |
| K040780 | ELECTROSURGICAL PENCILS | Hangzhou Shuyou Medical Instrument Company, Ltd. | 2005-02-10 | Traditional | PDF ↗ |
| K050161 | SYSTEM 7500-B ELECTROSURGICAL UNIT; ABCFLEX PROBE FOR FLEXIBLE ENDOSCOPY | Conmed Electrosurgery | 2005-02-03 | Special | PDF ↗ |
| K050102 | E-Z PEN, REUSEABLE HANDSWITCHING PENCIL | Megadyne Medical Products, Inc. | 2005-02-01 | Traditional | PDF ↗ |
| K043402 | THERMAGE THERMACOOL SYSTEM | Thermage, Inc. | 2005-01-14 | Traditional | PDF ↗ |
| K043273 | LIGASURE VESSEL SEALING SYSTEM. LIGASURE INSTRUMENTS | Valleylab | 2005-01-05 | Traditional | PDF ↗ |
| K043291 | CARDIOBLATE DISPERSIVE ELECTRODE ADAPTER (ACCESSORY), MODEL 60884 | Medtronic Vascular | 2004-12-21 | Special | PDF ↗ |
| K041810 | SERFAS ENERGY SYSTEM | Stryker Endoscopy | 2004-12-21 | Traditional | PDF ↗ |
| K033095 | SMOKE EVACUATION ATTACHEMENT | Modern Medical Equipment Mfg., Ltd. | 2004-11-17 | Traditional | PDF ↗ |
| K043008 | SURGRX ENSEAL VESSEL SEALING & HEMOSTASIS SYSTEM | Surgrx, Inc. | 2004-11-17 | Special | PDF ↗ |
| K042909 | STELLARTECH COAGULATION SYSTEM, MODELS 1100C-115A & 1100C-230A | Stellartech Research Corp. | 2004-11-12 | Special | PDF ↗ |
| K042216 | COOL-TIP RF ABLATION SYSTEM | Valleylab | 2004-11-12 | Traditional | PDF ↗ |
| K041968 | GENICON BIPOLAR FORCEPS MODEL # 600-005-005 | Genicon | 2004-11-03 | Abbreviated | PDF ↗ |
| K042077 | BITECH BIPOLAR SCISSORS | Guenter Bissinger Medizintechnik GmbH | 2004-10-27 | Traditional | PDF ↗ |
| K042604 | VALLY FORGE SCIENTIFIC MALIS BIPOLAR DISPOSABLE FINGER OPERATED ELECTROSURGICAL INSTRUMENTS | Valley Forge Scientific Corp. | 2004-10-22 | Special | PDF ↗ |
| K041633 | GYRUS PLASMACISION LAPAROSCOPIC SPATULA | Gyrus Medical, Inc. | 2004-10-22 | Traditional | PDF ↗ |
| K042608 | TECNO REUSABLE BIPOLAR CABLES, MODEL 190-100 AND 190-110 | Tecno Instruments (Pvt.) , Ltd. | 2004-10-18 | Traditional | PDF ↗ |
| K033421 | ERBE BICLAMP OPEN AND LAPAROSCOPIC INSTRUMENTS | Erbe USA, Inc. | 2004-10-14 | Abbreviated | PDF ↗ |
| K041868 | VALUPEN,PROFILE | Conmed Corporation | 2004-09-28 | Traditional | PDF ↗ |
| K041587 | LIGASURE PRECISE MODEL #LS1200/LIGASURE 5MM LAPAROSCOPIC SEALER DIVIDER MODEL # LS1500 | Valleylab | 2004-09-28 | Traditional | PDF ↗ |
| K041285 | GYRUS G3 SYSTEM (GENERATOR, ASSESSORIES, SOMNOPLASTY ELECTRODES AND PLASMACISION ELECTRODES) | Gyrus Medical , Ltd. | 2004-09-10 | Traditional | PDF ↗ |
| K042170 | EN-BLOC BIOPSY SYSTEM MODEL#777-110,777-001,777-002,777-006,777-301,777-302,777-115,777-120 | Neothermia Corporation | 2004-09-07 | Special | PDF ↗ |
| K041981 | GUIDANT VASOVIEW 6 HARVESTING CANNULA, MODEL VH-2000; GUIDANT VASOVIEW 6 ACCESSORY PACK, MODEL VH-2004 | Guidant Corporation | 2004-08-20 | Special | PDF ↗ |
| K042098 | SENORX INTRODUCER | Senorx, Inc. | 2004-08-19 | Special | PDF ↗ |
| K033027 | SHINMED VARIOUS MODELS OF ELECTRO-SURGICAL PENCILS, SW12200, SW12202, SW12300 | Shining World Health Care Co., Ltd. | 2004-08-12 | Traditional | PDF ↗ |
| K041980 | MSI S-500L RF GENERATOR | Medsphere International, Inc. | 2004-08-06 | Special | PDF ↗ |
| K030819 | PLASMAJET SYSTEM | Plasma Surgical, Ltd. | 2004-08-05 | Traditional | PDF ↗ |
| K041328 | SMITH & NEPHEW ELECTROBLADE RESECTOR/ADAPTOR | Smith & Nephew, Inc. | 2004-07-27 | Traditional | PDF ↗ |
| K041599 | COBRA ADHERE SURGICAL SYSTEM | Estech, Inc. | 2004-07-27 | Traditional | PDF ↗ |
| K033592 | REPROCESSED SURGICAL SCISSORS AND GRASPERS | Clearmedical, Inc. | 2004-07-27 | Traditional | PDF ↗ |
| K040135 | THERMAGE THERMACOOL SYSTEM | Thermage, Inc. | 2004-06-21 | Traditional | PDF ↗ |
| K032327 | MODERN MEDICAL BIPOLAR FORCEPS | Modern Medical Equipment Mfg., Ltd. | 2004-06-15 | Traditional | PDF ↗ |
| K030831 | LAPASCOPIC INSTRUMENTS AND ELECTRODE TIPS | Modern Medical Equipment Mfg., Ltd. | 2004-06-15 | Traditional | PDF ↗ |
| K041383 | STELLARTECH COAGULATION SYSTEM, MODELS 1100C-115 AND 1100C-230 | Stellartech Research Corp. | 2004-06-14 | Special | PDF ↗ |
| K040638 | VNUS RADIOFREQUENCY GENERATOR, MODEL RFG2 | Vnus Medical Technologies, Inc. | 2004-06-07 | Traditional | PDF ↗ |
| K040699 | LAPAROSCOPIC ELECTRODE, REUSABLE INDICATOR SHAFT (LERIS) | Megadyne Medical Products, Inc. | 2004-06-04 | Traditional | PDF ↗ |
| K041347 | MODIFICATION TO EN-BLOC BIOPSY SYSTEM | Neothermia Corp. | 2004-06-04 | Special | PDF ↗ |
| K032965 | LAPAROSCOPIC INSTRUMENT, ELECTRODE AND CABLE | Modern Medical Equipment Mfg., Ltd. | 2004-05-13 | Traditional | PDF ↗ |
| K033003 | SUCTION COAGULATOR | Modern Medical Equipment Mfg., Ltd. | 2004-05-13 | Traditional | PDF ↗ |
| K040785 | CONCERTO BIPOLAR NEEDLE ELECTRODE | Boston Scientific Corp | 2004-04-28 | Special | PDF ↗ |
| K040989 | RITA SYSTEMS | Rita Medical Systems | 2004-04-28 | Traditional | PDF ↗ |
| K040584 | NMX-1000 | Neomedix Corp. | 2004-04-22 | Traditional | PDF ↗ |
| K040855 | INSTRUMED LAPAROSCOPE AND ACCESSORIES | Instrumed International, Inc. | 2004-04-16 | Traditional | PDF ↗ |
| K040763 | RESECT MEDICAL INLINE BI-POLAR RF LINEAR COAGULATION DEVICE | Resect Medical, Inc. | 2004-04-08 | Traditional | PDF ↗ |
| K033888 | MSI MODEL S-500 RF GENERATOR | Medsphere International, Inc. | 2004-04-02 | Traditional | PDF ↗ |
| K040240 | STELLARTECH COAGULATION SYSTEM (MODELS 1100C-115 & 1100C-230) | Stellartech Research Corp. | 2004-04-01 | Special | PDF ↗ |
| K033880 | ELECTRO-LUBE | Mectra Labs, Inc. | 2004-03-10 | Traditional | PDF ↗ |
| K040279 | VIVARING MICROWAVE ABLATION PROBE | Vivant Medical, Inc. | 2004-03-02 | Special | PDF ↗ |
| K040338 | ARTHROCARE CONTROLLER, CABLE, FOOT CONTROL, POWER CORD, WANDS, MODELS H0970-02, H2000-04, H2000-05, H0970-06 | Arthrocare Corp. | 2004-03-01 | Special | PDF ↗ |
| K033232 | COLORADO MICRODISSECTION NEEDLE | Stryker Corp. | 2004-02-25 | Traditional | PDF ↗ |
| K033981 | SMITH & NEPHEW ELECTROTHERMAL 20S SPINE GENERATOR, MODEL 7209975 | Smith & Nephew, Inc. | 2004-02-25 | Traditional | PDF ↗ |
| K040219 | COBRA SURGICAL PROBE | Boston Scientific Corp | 2004-02-24 | Special | PDF ↗ |
| K040104 | COBRA ADHERE SURGICAL SYSTEM, MODEL M00415977C0 | Boston Scientific Corp | 2004-02-18 | Special | PDF ↗ |
| K033205 | MANOA BREAST BIOPSY SYSTEM | Manoa Medical, Inc. | 2004-02-18 | Traditional | PDF ↗ |
| K033089 | HEMOSTATIX, MODEL 2400Z THERMAL SCALPEL SYSTEM | Gyrus Ent LLC | 2004-02-05 | Traditional | PDF ↗ |
| K032969 | HELICA TC LAPAROSCOPIC CUTTING AND CAUTERISING (LTC) PROBE | Helica Instruments, Ltd. | 2004-02-04 | Traditional | PDF ↗ |
| K033652 | MINIMALLY INVASIVE SOLUTIONS OSTEOTOMY GUIDE INSTRUMENT | Zimmer, Inc. | 2004-02-04 | Traditional | PDF ↗ |
| K033942 | THERMAGE THERMACOOL SYSTEM | Thermage, Inc. | 2004-02-04 | Traditional | PDF ↗ |
| K033547 | VNUS VESSEL AND TISSUE COAGULATION SYSTEM | Vnus Medical Technologies, Inc. | 2004-01-07 | Traditional | PDF ↗ |
| K031869 | SISS INC. (D.B.A. MEDISISS) REPROCESSED ELECTROSURGICAL INSTRUMENTS AND ACCESSORIES | Surgical Instruments Service and Savings, Inc. | 2003-12-24 | Traditional | PDF ↗ |
| K033748 | TRIDENT RESECTION ABLATOR | Linvatec Corp. | 2003-12-15 | Special | PDF ↗ |
| K033584 | ARTHROCARE ARTHROWANDS | Arthrocare Corp. | 2003-11-28 | Special | PDF ↗ |
| K033499 | MALIS IRRIGATION MODULE 1000 | Valley Forge Scientific Corp. | 2003-11-28 | Special | PDF ↗ |
| K024286 | GYRUS OPEN FORCEPS | Gyrus Medical, Inc. | 2003-11-17 | Traditional | PDF ↗ |
| K033257 | ARTHROCARE ENT PLASMA WANDS | Arthrocare Corp. | 2003-10-30 | Special | PDF ↗ |
| K032223 | COOK VASCULAR PERFECTA ELECTROSURGICAL DISSECTION SYSTEM ERGONOMIC INTERMITTENT ACTIVATION SWITCH | Cook Vascular, Inc. | 2003-10-15 | Traditional | PDF ↗ |
| K031564 | CSS | Medical Scientific, Inc. | 2003-10-07 | Special | PDF ↗ |
| K032721 | MODIFICATION TO: STELLARTECH COAGULATION SYSTEM (MODELS 1100C-115 & 1100C-230) | Stellartech Research Corp. | 2003-10-06 | Special | PDF ↗ |
| K032702 | VIVATIP MICROWAVE ABLATION PROBE | Vivant Medical, Inc. | 2003-10-03 | Special | PDF ↗ |
| K032838 | CELON ENT SYSTEM | Celon AG Medical Instruments | 2003-09-26 | Traditional | PDF ↗ |
| K032584 | RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 30629 | Rubicor Medical, Inc. | 2003-09-17 | Special | PDF ↗ |
| K031951 | TRANSDISCAL SYSTEM (TRANSDISCAL PROBE), MODEL TDP-17-150-6 | Baylis Medical Co., Inc. | 2003-09-11 | Traditional | PDF ↗ |
| K032149 | RITA MODEL 1500X ELECTROSURGICAL RF GENERATOR | Rita Medical Systems, Inc. | 2003-09-09 | Traditional | PDF ↗ |
| K032504 | ARTHROCARE SYSTEM | Arthrocare Corp. | 2003-08-21 | Special | PDF ↗ |
| K032452 | MODIFICATION TO: STELLARTECH COAGULATION SYSTEM, MODELS 1100C-115 & 100C-230 | Stellartech Research Corp. | 2003-08-21 | Special | PDF ↗ |
| K032132 | TISSUELINK FLOATING BALL MODEL 23-201-1 | Tissuelink Medical, Inc. | 2003-08-20 | Special | PDF ↗ |
| K032207 | COBRA COOLED SURGICAL PROBE, MODEL M004159670 | Boston Scientific Corp | 2003-08-20 | Special | PDF ↗ |
| K032047 | TRI-LOOP MICROWAVE ABLATION PROBE | Vivant Medical, Inc. | 2003-08-06 | Special | PDF ↗ |
| K032088 | MODIFICATION TO THERMACOOL TC SYSTEM | Thermage, Inc. | 2003-08-01 | Special | PDF ↗ |
| K032062 | STELLARTECH COAGULATION SYSTEM, MODELS (1100C-115 & 1100C-230) | Stellartech Research Corp. | 2003-07-29 | Special | PDF ↗ |
| K031846 | CARDIOVATIONS OPTICAL BIPOLAR DEVICE | ETHICON, Inc. | 2003-07-21 | Special | PDF ↗ |
| K031085 | GYRUS PLASMAKINETIC SUPERPULSE SYSTEM (GENERATOR, ACCESSORIES) | Gyrus Medical, Inc. | 2003-07-21 | Traditional | PDF ↗ |
| K030158 | UNIT, CAUTERY, TEHRMAL,BATTERY-POWERED | Walsh Medical Devices, Inc. | 2003-07-17 | Traditional | PDF ↗ |
| K031926 | RITA MODEL 1500X ELECTROSURGICAL RF GENERATOR AND ACCESSORIES (E.G., RITA THERMO PAD AND CABLE ADAPTER) | Rita Medical Systems, Inc. | 2003-07-17 | Special | PDF ↗ |
| K031950 | BAYLIS PAIN MANAGEMENT GENERATOR, MODELS PMG-115-TD AND PMG-230-TD | Baylis Medical Co., Inc. | 2003-07-17 | Abbreviated | PDF ↗ |
| K031247 | CARDIOBLATE BIPOLAR RADIOFREQUENCY SURGICAL ABLATION SYSTEM | Medtronic Vascular | 2003-07-17 | Traditional | PDF ↗ |
| K031133 | SURGRX ENSEAL VESSEL SEALING AND HEMOSTASIS SYSTEM INCLUDING THE ENSEAL CONTROLLER ADAPTER, ENSEAL OPEN AND LAPAROSCOPIS | Surgrx, Inc. | 2003-07-03 | Traditional | PDF ↗ |
| K031675 | SMITH & NEPHEW DYONICS ELECTROBLADE RESECTOR | Smith & Nephew, Inc. | 2003-06-20 | Special | PDF ↗ |
| K030720 | ULTRABLATOR ELECTRODE | Linvatec Corp. | 2003-06-03 | Traditional | PDF ↗ |
| K030996 | MSI SA ELECTRODES | Medsphere International, Inc. | 2003-05-30 | Traditional | PDF ↗ |
| K031011 | LIGASURE 5MM LAPAROSCOPIC SEALER-DIVIDER, MODEL LS1500 | Valleylab, Inc. | 2003-05-29 | Traditional | PDF ↗ |
| K031371 | SAPHYRE BIPOLAR ABLATION PROBES | Smith & Nephew, Inc. | 2003-05-23 | Traditional | PDF ↗ |
| K031046 | THERMACOOL TC SYSTEM | Thermage, Inc. | 2003-05-22 | Special | PDF ↗ |
| K023566 | CODMAN ISOCOOL BIPOLAR FORCEPS | Codman & Shurtleff, Inc. | 2003-05-22 | Traditional | PDF ↗ |
| K031082 | EVEREST BIPOLAR L HOOK & PK BIPOLAR L HOOK | Gyrus Medical, Inc. | 2003-05-21 | Special | PDF ↗ |
| K031081 | EVEREST LP BIPOLAR SCISSORS AND GYRUS LP BIPOLAR SCISSORS | Gyrus Medical, Inc. | 2003-05-21 | Special | PDF ↗ |
Product code GEI · Class II · General, Plastic Surgery. Data: openFDA.