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 22 of 24
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K873595 | SURGICAL PENCIL/ ELECTROSURGICAL PENCIL | Yuntek International, Inc. | 1987-10-26 | Traditional | PDF ↗ |
| K873591 | A.R.M. (ASPEN RETURN MONITOR) | Qmed, Inc. | 1987-09-30 | Traditional | PDF ↗ |
| K872705 | BOVIE 400-CT ELECTROSURGICAL GENERATOR (UNIT) | Clinical Technology Corp. | 1987-09-01 | Traditional | PDF ↗ |
| K871077 | MODEL CBC-1 COA COMP ANTI-STICKING BIPOLAR COAG. | Radionics, Inc. | 1987-06-12 | Traditional | PDF ↗ |
| K871910 | SURGITEK DISPOSABLE BIPOLAR CORD | Dermacare Products, Inc. | 1987-06-01 | Traditional | PDF ↗ |
| K870981 | MODEL 8700 BIPOLAR ELECTROSURGICAL GENERATOR | Everest Medical Corp. | 1987-05-06 | Traditional | PDF ↗ |
| K870149 | MODEL CBC-1 COA-COMP ANTI-STICKING BIOPOLAR COAG. | Radionics, Inc. | 1987-04-06 | Traditional | PDF ↗ |
| K870397 | AARON C SIZE(TM) HIGH TEMPERATURE CAUTERY | Sunkey Medical Manufacturing, Inc. | 1987-03-18 | Traditional | PDF ↗ |
| K870269 | ELECTROSURGICAL MENISCUS CUTTER (EMC) MOD. AMC-100 | American Bentley | 1987-03-09 | Traditional | PDF ↗ |
| K864771 | CHUCK HANDLE | New England Surgical Instrument Corp. | 1987-02-04 | Traditional | PDF ↗ |
| K864402 | BIPOLAR ELECTROSURGICAL INTRAOCULAR PROBE | New England Surgical Instrument Corp. | 1987-01-20 | Traditional | PDF ↗ |
| K864851 | MODEL FORCE 100 BIPOLAR ELECTROSURGICAL GENERATOR | Valleylab, Inc. | 1987-01-08 | Traditional | PDF ↗ |
| K864675 | MODEL FORCE 4B ELECTROSURGICAL GENERATOR | Valleylab, Inc. | 1987-01-08 | Traditional | PDF ↗ |
| K863731 | ROTARY* POWERED SCALPEL | Self Sharpening Surgical Steel, Inc. | 1986-10-17 | Traditional | PDF ↗ |
| K863701 | MODEL 709 BIPOLAR MICRO COAGULATOR | Bergen Mfg. | 1986-10-14 | Traditional | PDF ↗ |
| K862753 | TANDEM SUCTION CAUTERY | Celebration Designs, Inc. | 1986-10-03 | Traditional | PDF ↗ |
| K863412 | BIPOL CABLE | Treace Medical, Inc. | 1986-10-02 | Traditional | PDF ↗ |
| K863413 | BIPOLFORCEPS | Treace Medical, Inc. | 1986-10-02 | Traditional | PDF ↗ |
| K863414 | MICROBIPOLATOR | Treace Medical, Inc. | 1986-09-17 | Traditional | PDF ↗ |
| K863360 | NEOMED NON GEL-R TOTAL ADHESIVE CONDUCT. ELECTRODE | Richards Medical Co., Inc. | 1986-09-12 | Traditional | PDF ↗ |
| K862221 | E-Z CLEAN | American Medical Products, Inc. | 1986-09-12 | Traditional | PDF ↗ |
| K861742 | ELECTRO-SURGICAL PENCILS | Stryker Corp. | 1986-07-23 | Traditional | PDF ↗ |
| K861614 | GHI WET PENCIL | Surgical Products Corp. | 1986-07-08 | Traditional | PDF ↗ |
| K861495 | ELECTROSURGICAL BLADE ELECTRODE (SOLID TYPE) | National Wire & Stamping, Inc. | 1986-06-19 | Traditional | PDF ↗ |
| K861595 | BALL ELECTRODES | National Wire & Stamping, Inc. | 1986-06-19 | Traditional | PDF ↗ |
| K861372 | ELECTROSURGICAL CUTTING AND COAGULATION ACCESSORY | Snowden-Pencer | 1986-06-19 | Traditional | PDF ↗ |
| K861594 | ELECTROSURGICAL NEEDLE ELECTRODE (SOLID TYPE) | National Wire & Stamping, Inc. | 1986-06-19 | Traditional | PDF ↗ |
| K861112 | MODEL E2517 AND MODEL E2503 POWER CONTROL PENCILS | Valleylab, Inc. | 1986-05-20 | Traditional | PDF ↗ |
| K861139 | ADULT TDS ELECTROSURGICAL GROUNDING PAD (R.E.M.) | Conmedcorp | 1986-05-09 | Traditional | PDF ↗ |
| K861036 | E7509 POLYHESIVE II PATIENT RETURN ELECTRODE | Valleylab, Inc. | 1986-05-06 | Traditional | PDF ↗ |
| K855084 | PREMIE T.D.S. ELECTROSURGICAL GROUNDING PAD | Conmedcorp | 1986-05-06 | Traditional | PDF ↗ |
| K854231 | ELECTROSURGICAL CUTTING & COAGULATION DEVICE/ACCES | Clinical Technology Corp. | 1986-05-02 | Traditional | PDF ↗ |
| K860479 | GREEN-LINE BIPOLAR COAGULATION UNIT | Grieshaber & Co. | 1986-05-01 | Traditional | PDF ↗ |
| K860718 | ELECTROSURGERY PENCIL, MODEL 767 | Birtcher Corp. | 1986-03-24 | Traditional | PDF ↗ |
| K860687 | BIRT-A-SWITCH, DSP PUSH BUTTON, MODEL NO. 768 | Birtcher Corp. | 1986-03-24 | Traditional | PDF ↗ |
| K860236 | PHAKOSYSTEMS CT-100 CAUTERY MODULE | Phakosystems, Inc. | 1986-02-19 | Traditional | PDF ↗ |
| K853972 | CAMERON-MILLER MODEL 80-2701, BIPOLAR COAGULATOR | Cameron-Miller, Inc. | 1986-01-24 | Traditional | PDF ↗ |
| K854109 | ELECTROSURGICAL DEVICES, 26-0330,26-335,340 & 0345 | Cameron-Miller, Inc. | 1986-01-24 | Traditional | PDF ↗ |
| K854814 | SURGICAL CAUTERIES MODELS 775-11,12,13,31,32 & 33 | Birtcher Corp. | 1986-01-13 | Traditional | PDF ↗ |
| K854864 | BI-POLAR FORCEPS | Birtcher Corp. | 1985-12-24 | Traditional | PDF ↗ |
| K854592 | MALIS MICRO BIPOLAR COAGULATOR | Valley Forge Scientific Corp. | 1985-12-17 | Traditional | PDF ↗ |
| K854413 | MALIS IRRIGATION SYSTEM | Valley Forge Scientific Corp. | 1985-12-02 | Traditional | PDF ↗ |
| K853968 | DIATEMP ELECTROSURGICAL PEN | Ndm Corp. | 1985-11-14 | Traditional | PDF ↗ |
| K852942 | WORLD PORTABLE CAUTERY | Sturgeon Engineering Co. | 1985-10-10 | Traditional | PDF ↗ |
| K852935 | ESCHMANN ELECTROSURGICAL UNIT, MODEL TD411 | Eschmann Bros. & Walsh , Ltd. | 1985-10-10 | Traditional | PDF ↗ |
| K851304 | NON/GEL ADHESIVE DISPERSIVE ELECTRODE 3427,33-4270 | Richards Medical Co., Inc. | 1985-09-06 | Traditional | PDF ↗ |
| K851305 | NON/GEL FULLY ADHESIVE DISPERSIVE ELECTRODE 3428, | Richards Medical Co., Inc. | 1985-09-06 | Traditional | PDF ↗ |
| K852355 | SINGLE USE ARTHROSCOPY ELECTRODE | Aspen Laboratories, Inc. | 1985-09-03 | Traditional | PDF ↗ |
| K853168 | MALIS BIPOLAR PEN | Valley Forge Scientific Corp. | 1985-08-12 | Traditional | PDF ↗ |
| K852683 | ELECTROSURGICAL LATERAL RELEASE PROBE MOD ALR-100 | American Bentley | 1985-08-12 | Traditional | PDF ↗ |
| K851040 | CONCEPT DEFRERE ELECTRODE | Concept, Inc. | 1985-07-11 | Traditional | PDF ↗ |
| K844780 | EUROPLATE-CONDUCTIVE ADHESIVE ELECTROSURGICAL RETU | Poly- Med, Inc. | 1985-05-21 | Traditional | PDF ↗ |
| K850668 | ELECTROSURGICAL UNIT 774 | Birtcher Corp. | 1985-05-20 | Traditional | PDF ↗ |
| K850943 | MODEL 775 BIPOLAR COAGULATOR | Birtcher Corp. | 1985-05-20 | Traditional | PDF ↗ |
| K851487 | CODMAN DISPOSABLE BIPOLAR CARD | Codman & Shurtleff, Inc. | 1985-05-03 | Traditional | PDF ↗ |
| K844816 | MATRIX 101 NEGATIVE GALVANIC GENERATOR | Prn Medical | 1985-04-04 | Traditional | PDF ↗ |
| K850297 | ELECTROSURGICAL PENCIL HOLDER 720 | Birtcher Corp. | 1985-02-28 | Traditional | PDF ↗ |
| K850129 | MODIFIED CONDUCTIVE ADHESIVE ELECTROSURGICAL GROUN | Consolidated Medical Equipment, Inc. | 1985-02-28 | Traditional | PDF ↗ |
| K843974 | VARIABLE TEMPERATURE CAUTERY DEVICE | National Patent Development Corp. | 1985-02-26 | Traditional | PDF ↗ |
| K844372 | HAND CONTROLLED ELECTROSURGICAL PENCIL DISPOSABLE | Consolidated Medical Equipment, Inc. | 1985-02-21 | Traditional | PDF ↗ |
| K844565 | BOVIE X-10 ELECTROSURGICAL GENERATOR(UNIT) | Clinical Technology Corp. | 1985-02-21 | Traditional | PDF ↗ |
| K844371 | HAND CONTROLLED ELECTROSURGICAL PENCIL-REUSEABLE | Consolidated Medical Equipment, Inc. | 1985-02-20 | Traditional | PDF ↗ |
| K844428 | RADIOTOM 804 | Siemens Medical Solutions USA, Inc. | 1985-02-20 | Traditional | PDF ↗ |
| K844403 | MODEL FORCE 2 ELECTROSURGICAL GENERATOR | Valleylab, Inc. | 1985-02-20 | Traditional | PDF ↗ |
| K844004 | ESCHMANN TDB50 BIPOLAR COAGULATION | Storz Instrument Co. | 1984-12-12 | Traditional | PDF ↗ |
| K841459 | REPLACE-A-TIP ADJUST. LOW TEMP.- | Suncoast Medical Manufacturers, Inc. | 1984-12-07 | Traditional | PDF ↗ |
| K841604 | ADJUST-A-TEMP HIGH TEMPERATURE | Suncoast Medical Manufacturers, Inc. | 1984-12-07 | Traditional | PDF ↗ |
| K841509 | REPLACE-A-TIP ADJUSTABLE HIGH TEMP. | Suncoast Medical Manufacturers, Inc. | 1984-12-07 | Traditional | PDF ↗ |
| K841603 | ADJUST-A-TEMP MICRO | Suncoast Medical Manufacturers, Inc. | 1984-12-07 | Traditional | PDF ↗ |
| K841591 | PYRO-TIP | Suncoast Medical Manufacturers, Inc. | 1984-10-31 | Traditional | PDF ↗ |
| K840376 | SURG-A STAT LOOP TIP | Suncoast Medical Manufacturers, Inc. | 1984-10-26 | Traditional | PDF ↗ |
| K842622 | HEMO STATIC/ESU SCALPEL SYSTEM | Oximetrix, Inc. | 1984-10-23 | Traditional | PDF ↗ |
| K841483 | ALL PURPOSE ELECTROSURGICAL GENERATOR | Concept, Inc. | 1984-10-23 | Traditional | PDF ↗ |
| K842596 | MICROPENCIL | Surgical Safety | 1984-10-10 | Traditional | PDF ↗ |
| K842595 | MICROELECTRODE | Surgical Safety | 1984-10-10 | Traditional | PDF ↗ |
| K842574 | THE CLINICIAN | Solidstate Systems Corp. | 1984-09-25 | Traditional | PDF ↗ |
| K840375 | SURG-A-STAT LOOP TIP 15 | Suncoast Medical Manufacturers, Inc. | 1984-07-23 | Traditional | PDF ↗ |
| K840377 | SURG-A-STAT CARDIOVASCULAR TIP | Suncoast Medical Manufacturers, Inc. | 1984-07-23 | Traditional | PDF ↗ |
| K840387 | SURG-A-STAT LOOP TIP 2 | Suncoast Medical Manufacturers, Inc. | 1984-07-23 | Traditional | PDF ↗ |
| K840434 | REPLACE-A-TIP LOW TEMP. CAUTERY | Suncoast Medical Manufacturers, Inc. | 1984-04-25 | Traditional | PDF ↗ |
| K840433 | REPLACE-A-TIP HIGH TEMP. CAUTERY | Suncoast Medical Manufacturers, Inc. | 1984-04-25 | Traditional | PDF ↗ |
| K834434 | MACH I ELECTROSURGERY HAND CONTROL | Surgical Products Corp. | 1984-04-25 | Traditional | PDF ↗ |
| K840585 | SURG-A-STAT FINE TIP 2 | Suncoast Medical Manufacturers, Inc. | 1984-04-23 | Traditional | PDF ↗ |
| K834329 | OLSEN 756 ROCKER SWITCHPEN | Olsen Electro-Surgical Instruments, Inc. | 1984-04-04 | Traditional | PDF ↗ |
| K834048 | BOVIE CONDUCTIVE ADHES-DISPER-ELECTRO | Castle Co. | 1984-04-04 | Traditional | PDF ↗ |
| K834410 | DOUBLE-COAGULATION SWITCHPEN 757 | Olsen Electro-Surgical Instruments, Inc. | 1984-04-04 | Traditional | PDF ↗ |
| K831489 | SURGICAL TUBE HOLDER | The Urology Group | 1983-12-12 | Traditional | PDF ↗ |
| K833449 | HAND CONTROLLED PENCIL OR SWITCH HAND | Cameron-Miller, Inc. | 1983-11-29 | Traditional | PDF ↗ |
| K833364 | 3M SCOTCHPLATE II DISPERSIVE ELECTRODE | 3M Company | 1983-11-29 | Traditional | PDF ↗ |
| K833441 | DRY GEL | Concept, Inc. | 1983-11-29 | Traditional | PDF ↗ |
| K833015 | BIOPLAR CORD -DISPOSABLE 30-1538 | Codman & Shurtleff, Inc. | 1983-10-14 | Traditional | PDF ↗ |
| K832157 | DELTA CONDUCTIVE ADHESIVE ELECTROSURG- | Delta Medical Electronics, Inc. | 1983-07-26 | Traditional | PDF ↗ |
| K831508 | MALIS CMC-II BIPOLAR COAGULATOR & CUT | Valley Forge Scientific Corp. | 1983-06-24 | Traditional | PDF ↗ |
| K831290 | ELECTRODE, FLEXIBLE SUCTION COAGULATOR | Aspen Laboratories, Inc. | 1983-06-03 | Traditional | PDF ↗ |
| K831299 | EVEN-TEMP. CAPACITIVE ADHESIVE PAD | Delta Medical Electronics, Inc. | 1983-06-02 | Traditional | PDF ↗ |
| K831291 | ELECTROSURGICAL UNIT-MF 380 #60-1700 | Aspen Laboratories, Inc. | 1983-06-02 | Traditional | PDF ↗ |
| K830926 | 160/260 SUCTION COAGULATOR | Zimmer, Inc. | 1983-06-02 | Traditional | PDF ↗ |
| K831236 | BIPOLAR CARD | New England Surgical Instrument Corp. | 1983-06-02 | Traditional | PDF ↗ |
| K830925 | MF 380 ELECTROSURGICAL UNIT | Zimmer, Inc. | 1983-05-13 | Traditional | PDF ↗ |
| K830532 | ELECTROSURGICAL CAULTERY PENCIL | American V. Mueller | 1983-04-27 | Traditional | PDF ↗ |
Product code GEI · Class II · General, Plastic Surgery. Data: openFDA.