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 18 of 24
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K955618 | BIPOLAR CUTTER | Cook Urological, Inc. | 1996-01-22 | Traditional | PDF ↗ |
| K953271 | ELMED RF-ALERT | Elmed, Inc. | 1996-01-18 | Traditional | PDF ↗ |
| K955501 | THE TULIP MONO POLAR ROTATABLE ALLIGATOR FORCEP | The Tulip Mfg. Co. | 1996-01-17 | Traditional | PDF ↗ |
| K955502 | THE TULIP MONO POLAR ROTATABLE METZ SCISSORS | The Tulip Mfg. Co. | 1996-01-17 | Traditional | PDF ↗ |
| K955467 | NEUROVIEW COAXIAL BIPOLAR ELECTRODE | Neuro Navigational Corp. | 1995-12-18 | Traditional | PDF ↗ |
| K955109 | VL2600 HANDSWITCHING PENCIL WITH HOLSTER | Valleylab, Inc. | 1995-12-18 | Traditional | PDF ↗ |
| K954965 | ZOMED MODEL 20 & 30 ELECTROSURGICAL PROBES | Zomed Intl. | 1995-12-18 | Traditional | PDF ↗ |
| K954439 | ORATEC INTERVENTIONS MODEL TAC 1000 MONOPOLAR CAUTERY PROBE | Oratec Interventions, Inc. | 1995-12-18 | Traditional | PDF ↗ |
| K955001 | EVERSHEARS SCISSORS, BILAP PROBES, BICOAG FORCEPS | Everest Medical Corp. | 1995-12-13 | Traditional | PDF ↗ |
| K953696 | COAGULATING CANNULA DEVICE | Dorsal Orthopedic Corp. | 1995-12-08 | Traditional | PDF ↗ |
| K955346 | VFS - 300 BIPOLAR ELECTROSURGERY SYSTEM | Valley Forge Scientific Corp. | 1995-12-08 | Traditional | PDF ↗ |
| K955035 | VIDAMED SERIES 7205 ELECTROSURGICAL GENERATOR | Vidamed, Inc. | 1995-11-29 | Traditional | PDF ↗ |
| K952231 | EMC MODEL STATOME 200 | Emc Industries | 1995-11-21 | Traditional | PDF ↗ |
| K954229 | ARGON ACCESSORY WITH BLADE & NEEDLE ELECTRODE, ADAPTER BOX | Valleylab, Inc. | 1995-11-20 | Traditional | PDF ↗ |
| K954851 | BIOPOLAR FORCEPS LINE | Johnson & Johnson Professionals, Inc. | 1995-11-14 | Traditional | PDF ↗ |
| K954871 | LAPAROSCOPIC INSTRUMENT GROUNDING SYSTEM | Conmedcorp | 1995-11-02 | Traditional | PDF ↗ |
| K954253 | STORZ S2060-C & DP9040 BIPOLAR CCORD ADAPTORS | Storz Instrument Co. | 1995-11-01 | Traditional | PDF ↗ |
| K953081 | BEAMER PLUS | Aspen Laboratories, Inc. | 1995-10-30 | Traditional | PDF ↗ |
| K953992 | LUMITROL CONTROLLER, LUMITROL HAND-CONTROLLED ELECTROSURGICAL PENCIL WITH BLADE ELECTRODE | Lmi Lightwave Medical Industries , Ltd. | 1995-10-23 | Traditional | PDF ↗ |
| K954633 | CONMED ELECTROSURGICAL GROUNDING PAD | Conmedcorp | 1995-10-23 | Traditional | PDF ↗ |
| K953889 | AMERICAN BIOSURGICAL ELECTROSURGICAL BIPOLAR CABLE/CORD | American Biosurgical, Inc. | 1995-10-18 | Traditional | PDF ↗ |
| K953738 | ERBOTOM ICC 300 | Erbe Electromedizin GmbH | 1995-10-16 | Traditional | PDF ↗ |
| K954321 | ENDOCARE MONOPOLAR ELECTRODES (MODIFICATION) | Cytocare, Inc. | 1995-10-13 | Traditional | PDF ↗ |
| K953479 | BIPOLAR FORCEPS | Megadyne Medical Products, Inc. | 1995-10-12 | Traditional | PDF ↗ |
| K952072 | ZOMED MODEL 500 ELECTROSURGICAL GENERATOR MODEL 200 ELECTROSURGICAL PROBE | Zomed Intl. | 1995-10-04 | Traditional | PDF ↗ |
| K953159 | ERBOTOM ICC BIPOLAR | Erbe USA, Inc. | 1995-10-04 | Traditional | PDF ↗ |
| K953446 | AESCULAP BIPOLAR CORDS | Aesculap, Inc. | 1995-09-29 | Traditional | PDF ↗ |
| K954056 | UNIVERSAL PLUS ES S/I INSTRUMENT | Conmedcorp | 1995-09-29 | Traditional | PDF ↗ |
| K945914 | BIPOLAR GENERATOR MODEL 2352 | Richard Wolf Medical Instruments Corp. | 1995-09-26 | Traditional | PDF ↗ |
| K954088 | TELESCOPING PENEVAC | I.C Medical, Inc. | 1995-09-22 | Traditional | PDF ↗ |
| K954122 | TAKE-APART SCISSORS | KARL STORZ Endoscopy-America, Inc. | 1995-09-14 | Traditional | PDF ↗ |
| K952973 | THE TULIP MONO-POLAR CAUTERY SPATULA | The Tulip Mfg. Co. | 1995-09-11 | Traditional | PDF ↗ |
| K952792 | PADLESS ELECTROSURGICAL PENCIL | Lca, Inc. | 1995-08-28 | Traditional | PDF ↗ |
| K953737 | VL7600 REM PATIENT RETURN ELECTRODE | Valleylab, Inc. | 1995-08-23 | Traditional | PDF ↗ |
| K953195 | VALLEYLAB FORCE 300 | Valleylab, Inc. | 1995-08-21 | Traditional | PDF ↗ |
| K953007 | EXCALIBUR PLUS ELECTROSURGICAL UNIT | Aspen Laboratories, Inc. | 1995-08-21 | Traditional | PDF ↗ |
| K952698 | ENDOCARE ELECTROSURGICAL HANDPIECE | Cytocare, Inc. | 1995-08-14 | Traditional | PDF ↗ |
| K952110 | ELMED THERMO-FLUX | Elmed, Inc. | 1995-08-14 | Traditional | PDF ↗ |
| K944947 | ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESS | Boston Surgical Products, Inc. | 1995-07-28 | Traditional | PDF ↗ |
| K952832 | DISPOSABLE BIPOLAR ELECTRODE | Neuro Navigational Corp. | 1995-07-26 | Traditional | PDF ↗ |
| K952587 | ENDOCARE MONOPOLAR ELECTRODES | Cytocare, Inc. | 1995-07-17 | Traditional | PDF ↗ |
| K951905 | SCISSORS, UNIVERSAL, LAPAROSCOPIC W/MONOPOLAR CAUTERY REUSABLE | H.S. Intl. Co., Inc. | 1995-07-11 | Traditional | PDF ↗ |
| K952161 | BIPOLAR COAGULATION INSTRUMENT | Johnson & Johnson Professionals, Inc. | 1995-07-05 | Traditional | PDF ↗ |
| K952432 | SYMBIOSIS BIPOLAR FORCEPS | Symbiosis Corp. | 1995-07-05 | Traditional | PDF ↗ |
| K952524 | AESCULAP BIOPOLAR COAGULATOR | Aesculap, Inc. | 1995-06-29 | Traditional | PDF ↗ |
| K952726 | ULTRACISION HARMONIC SCAPEL | Ultracision, Inc. | 1995-06-23 | Traditional | PDF ↗ |
| K951659 | ZOMED MODEL 10 CAUTERY BIOPSY DEVICE | Zomed Intl. | 1995-06-19 | Traditional | PDF ↗ |
| K952577 | ELECTROSURGICAL DISPERSIVE ELECTRODE | Medtrex, Inc. | 1995-06-14 | Traditional | PDF ↗ |
| K950375 | DISPOSABLE & REUSABLE BIPOLAR SUCTION COAGULATOR | Boston Surgical Products, Inc. | 1995-06-14 | Traditional | PDF ↗ |
| K951230 | MICROSURGE BIPOLAR GRASPERS | Microsurge, Inc. | 1995-06-14 | Traditional | PDF ↗ |
| K945688 | VALLEYLAB PROCISION(TM) SYSTEM | Valleylab, Inc. | 1995-06-13 | Traditional | PDF ↗ |
| K951245 | VIDAMED 50 ELECTROSURGICAL GENERATOR, VIDAMED AEC (ADJUSTABLE ELECTROSURGICAL CARTRIDGE) ACCESSORY | Vidamed, Inc. | 1995-06-09 | Traditional | PDF ↗ |
| K946237 | ELECTROSURGICAL DEVICE, CUTTING AND COAGULATION AND ACCESSORIES | Megadyne Medical Products, Inc. | 1995-06-07 | Traditional | PDF ↗ |
| K945254 | ELECTROSURGICAL CUTTING & COAGULATION DEVICE ACCESSORIES | Endotec, Inc. | 1995-06-06 | Traditional | PDF ↗ |
| K946177 | VALLEYLAB NS 2000 BIPOLAR GENERATOR SYSTEM | Valleylab, Inc. | 1995-06-06 | Traditional | PDF ↗ |
| K944602 | VALLEYLAB FORCE FX | Valleylab, Inc. | 1995-06-05 | Traditional | PDF ↗ |
| K952204 | CONMED/ASPEN LABS COATED LAPAROSCOPIC ELECTROSURGICAL BLADES | Conmedcorp | 1995-05-25 | Traditional | PDF ↗ |
| K951732 | NEZHAT-DORESEY PENCIL-GRIP HANDLES | American Hydro-Surgical Instruments, Inc. | 1995-05-24 | Traditional | PDF ↗ |
| K951985 | PRECISION BIPOLAR COAGULATOR | Valley Forge Scientific Corp. | 1995-05-23 | Traditional | PDF ↗ |
| K950663 | BEI MEDICAL SYSTEMS MG-1000HS MONOPOLAR GENERATOR | Bei Medical Systems Co., Inc. | 1995-05-17 | Traditional | PDF ↗ |
| K951731 | NEZHAT-DORESY ELECTROSURGICAL HAND CONTROL ATTACHMENTS | American Hydro-Surgical Instruments, Inc. | 1995-05-16 | Traditional | PDF ↗ |
| K951912 | DISOPOSABLE & RESUABLE MONPOLAR CORD | Boston Surgical Products, Inc. | 1995-05-12 | Traditional | PDF ↗ |
| K944265 | NEEDLE ELCTRODE | Unimed Surgical Products, Inc. | 1995-05-05 | Traditional | PDF ↗ |
| K951589 | MANUAL SURGICAL INSRUMENT | United States Surgical, A Division of Tyco Healthc | 1995-05-03 | Traditional | PDF ↗ |
| K951328 | LMI MEDICAL, ELECTRODE, ELECTROSURGICAL, DISPOSABLE DISPERSIVE ELECTRODE WITH CORD | Labeltape Meditect, Inc. | 1995-04-25 | Traditional | PDF ↗ |
| K951269 | DISPOSABLE & REUSABLE MONOPOLAR HANDSWITHC PENCIL | Boston Surgical Products, Inc. | 1995-04-24 | Traditional | PDF ↗ |
| K945758 | HI-TIP HIGH TEMPERATURE REPLACEMENT TIP | Aaron Medical Industries | 1995-04-21 | Traditional | PDF ↗ |
| K950406 | DEVICE, ELECTROSURGICAL, CUTTING AND COAGULATION & ACCESSORIES | Aaron Medical Industries | 1995-04-13 | Traditional | PDF ↗ |
| K941435 | BIPOLAR U-SHAPE HANDLE, PRONGS, AND CORD | New Eder Corp. | 1995-04-11 | Traditional | PDF ↗ |
| K951035 | BIPOLAR FORCEPS | Megadyne Medical Products, Inc. | 1995-04-07 | Traditional | PDF ↗ |
| K946105 | ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESSORIES | Endoscopic Technologies, Inc. | 1995-04-06 | Traditional | PDF ↗ |
| K951353 | HYBRID SURGICAL DEVICES, MODIFICIATION | Laser Centers of America, Inc. | 1995-04-06 | Traditional | PDF ↗ |
| K951032 | FINESS I (DERMATOLOGIC APPLICATION) | Utah Medical Products, Inc. | 1995-04-06 | Traditional | PDF ↗ |
| K946104 | SMOKIEVAC ELECTROSURGICAL PENCIL | Aspen Laboratories, Inc. | 1995-04-03 | Traditional | PDF ↗ |
| K946377 | ELECTROPROBE SINGLE USE ELECTROSURGICAL PROBES | Ximed Medical Systems | 1995-03-24 | Traditional | PDF ↗ |
| K950932 | BIPOLAP HOOK ELECTRODE | Berchtold Holding GmbH | 1995-03-15 | Traditional | PDF ↗ |
| K950953 | KARL STORZ PEDIATRIC VANCAILLIE TAKE-APART BIPOLAR MICRO-FORCEPS, MANHES TAKE-APART BIPOLAR FORCEPS, VBIPOLAR COAGULATEE | KARL STORZ Endoscopy-America, Inc. | 1995-03-14 | Traditional | PDF ↗ |
| K950877 | REUSABLE MONOPOLAR FORCEPS | Boston Surgical Products, Inc. | 1995-03-09 | Traditional | PDF ↗ |
| K946246 | SURGI-LINK BIPOLAR MICRO FORCEPS | Unimed Surgical Products, Inc. | 1995-03-07 | Traditional | PDF ↗ |
| K950507 | NEZHAT-DORSEY LAPAROSCOPIC HAND INSTRUMENTS | American Hydro-Surgical Instruments, Inc. | 1995-03-06 | Traditional | PDF ↗ |
| K950347 | LEVEEN NEEDLE ELECTRODE(TM) | Radiotherapeutics Corp. | 1995-02-23 | Traditional | PDF ↗ |
| K945694 | NEZHAT-DORSEY BIPOLAR ELECTROSURGICAL FORCEPS, SURFACE ELECTRODES, AND CORDS | American Hydro-Surgical Instruments, Inc. | 1995-02-17 | Traditional | PDF ↗ |
| K950188 | VALLEYLAB COATED ELECTRODES | Valleylab, Inc. | 1995-02-10 | Traditional | PDF ↗ |
| K945531 | BLADE ELECTRODE | E & M Engineering, Inc. | 1995-02-10 | Traditional | PDF ↗ |
| K945317 | NEZHAT-DORSEY (TM) ELECTROSHIELD(TM) PROBES AND ACCESSORIES | American Hydro-Surgical Instruments, Inc. | 1995-02-01 | Traditional | PDF ↗ |
| K945995 | BIPOLAR ELECTROSURGICAL PROBES AND INSTRUMENTS | Ximed/Prosure/Injectx | 1995-01-31 | Traditional | PDF ↗ |
| K945492 | HIGH TEMPERATURE CAUTERY | Aaron Medical Industries | 1995-01-30 | Traditional | PDF ↗ |
| K945757 | HIGH TEMPERATURE CAUTERY FINE ADJUSTABLE | Aaron Medical Industries | 1995-01-30 | Traditional | PDF ↗ |
| K945759 | HIGH TEMPERATURE CAUTERY 5 LOOP | Aaron Medical Industries | 1995-01-30 | Traditional | PDF ↗ |
| K945760 | HIGH TEMPERATURE CAUTERY | Aaron Medical Industries | 1995-01-30 | Traditional | PDF ↗ |
| K945765 | HIGH TEMPERATURE CAUTERY | Aaron Medical Industries | 1995-01-30 | Traditional | PDF ↗ |
| K944681 | LECTROSURIGICAL, CUTTING AND COAGULATION AND ACCESSORIES | Birtcher Medical Systems, Inc. | 1994-12-22 | Traditional | PDF ↗ |
| K944012 | ELECTROSURGICAL FLEXIBLE ELECTRODE IN-LINE SUCTION COAGULATOR | Aspen Laboratories, Inc. | 1994-12-21 | Traditional | PDF ↗ |
| K943055 | ELECTROSURGICAL CUTTING AND COAGULATING DEVICE AND ACCESSORIES | Megadyne Medical Products, Inc. | 1994-12-21 | Traditional | PDF ↗ |
| K945975 | EVERSHEARS(R) SCISSORS, BILAP(R) PROBES, BICOAG(R) FORCEPS | Everest Medical Corp. | 1994-12-21 | Traditional | PDF ↗ |
| K945898 | ELECTROSURGICAL DEVICE, CUTTING AND COAGULATION AND ACCESSORIES | Megadyne Medical Products, Inc. | 1994-12-13 | Traditional | PDF ↗ |
| K945805 | WELLS JOHNSON WECO MONOPOLAR/FRAZIER SUCTION PROBE | Wells Johnson Co. | 1994-12-13 | Traditional | PDF ↗ |
| K945893 | DISPOSABLE & REUSABLE MONOPOLAR ELECTROSURIGICAL ELECTRODE | Boston Surgical Products, Inc. | 1994-12-13 | Traditional | PDF ↗ |
| K944634 | ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESSORIES | Boston Surgical Products, Inc. | 1994-12-08 | Traditional | PDF ↗ |
| K944642 | ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESSORIES | Boston Surgical Products, Inc. | 1994-12-08 | Traditional | PDF ↗ |
Product code GEI · Class II · General, Plastic Surgery. Data: openFDA.