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 23 of 24
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K830613 | ELECTROSURGICAL GROUND PAD-DISPERSIVE | Con Med Equipment, Inc. | 1983-04-12 | Traditional | PDF ↗ |
| K830545 | DISPERSIVE ELECTRODE | C.R. Bard, Inc. | 1983-03-29 | Traditional | PDF ↗ |
| K823905 | SURGICAL BLADES | Designs IN Medicine | 1983-03-24 | Traditional | PDF ↗ |
| K830277 | DUOWIPE CAUTERY TIP & INSTRUMENT CLEANER | Ritmed, Inc. | 1983-03-08 | Traditional | PDF ↗ |
| K823923 | MF 360B ELECTROSURGICAL UNIT | Aspen Laboratories, Inc. | 1983-02-15 | Traditional | PDF ↗ |
| K823689 | 3M SCOTCHPLATE 51148 SMALL CONDUCTIVE | 3M Company | 1983-01-12 | Traditional | PDF ↗ |
| K823670 | E.S. PENCIL | Surgicare Scientific Laboratory, Inc. | 1983-01-12 | Traditional | PDF ↗ |
| K823924 | MODEL SSE4 ELECTROSURGICAL GENERATOR | Valleylab, Inc. | 1983-01-09 | Traditional | PDF ↗ |
| K823491 | BIRT-A-SWITCH DSP #712 | Birtcher Corp. | 1983-01-07 | Traditional | PDF ↗ |
| K821505 | AIRWAY TEMPERATURE SENSOR | Mon-A-Therm, Inc. | 1982-12-09 | Traditional | PDF ↗ |
| K823083 | ELECTROSURGICAL UNIT | Kelleher Corp. | 1982-12-07 | Traditional | PDF ↗ |
| K823184 | BIPOLAR COAGULATOR #9620/9621 | Concept, Inc. | 1982-12-03 | Traditional | PDF ↗ |
| K822355 | DISP. METAL & PLASTIC ELECTROSURG. DEV | Valleylab, Inc. | 1982-09-22 | Traditional | PDF ↗ |
| K822092 | CAMERON-MILLER #40-1516 | Cameron-Miller, Inc. | 1982-09-21 | Traditional | PDF ↗ |
| K822513 | MODEL #2000 HI-TEMP & #3000 LOW-TEMP | Surgicare Scientific Laboratory, Inc. | 1982-09-21 | Traditional | PDF ↗ |
| K822405 | CONDUCTIVE ADHESIVE DISPERSIVE ELECTRO | Edward Weck, Inc. | 1982-09-21 | Traditional | PDF ↗ |
| K822572 | POLYHESIVE PATIENT RETURN ELECTRODE | Valleylab, Inc. | 1982-09-21 | Traditional | PDF ↗ |
| K822070 | ELITE #MPS 101 ELECTROSURGICAL SWITCH | Delta Medical Electronics, Inc. | 1982-08-19 | Traditional | PDF ↗ |
| K822069 | ELIMINATOR #BPS 201 BIPOLAR ELECTRO | Delta Medical Electronics, Inc. | 1982-08-19 | Traditional | PDF ↗ |
| K822072 | MPI ELECTROSURGICAL CAPACTIVE DISPER | Medical Plastics, Inc. | 1982-08-19 | Traditional | PDF ↗ |
| K822062 | BALL TIP COAGULATING ELECTRODES | American Endoscopy, Inc. | 1982-08-19 | Traditional | PDF ↗ |
| K821169 | MPI MON-IT II, SMART SAFETY SYSTEM | Medical Plastics, Inc. | 1982-08-06 | Traditional | PDF ↗ |
| K821356 | DESERET CAPACITY PLUS ELECTROSURG. PAD | Warner-Lambert Co. | 1982-07-14 | Traditional | PDF ↗ |
| K821263 | SELECT BIPOLAR COAGULATION FORCEPS | ZEISS | 1982-06-10 | Traditional | PDF ↗ |
| K820857 | SAFE-T-SEAL | Wisconsin Scientific Corp. | 1982-06-01 | Traditional | PDF ↗ |
| K820971 | DIATHERMIC HANDLE FOR BIOPSY FORCEPS | Mill-Rose Laboratory | 1982-04-29 | Traditional | PDF ↗ |
| K820902 | MULTIPERFECTEMP | Kay Medical, Inc. | 1982-04-26 | Traditional | PDF ↗ |
| K820983 | HOT BIOPSY FORCEPS W/ROUND CUPS | Mill-Rose Laboratory | 1982-04-26 | Traditional | PDF ↗ |
| K820494 | SYBRON BOVIE CSV HAND CONTR. ELECTROSURG | Sybron Corp. | 1982-04-09 | Traditional | PDF ↗ |
| K820713 | BALLARD MEDICAL PRODUCTS ELECTRO-SURG | Ballard Medical Products | 1982-03-26 | Traditional | PDF ↗ |
| K820156 | THEIR ELECTRO SURGICAL COUTERY PENCIL | Shannon Group | 1982-02-18 | Traditional | PDF ↗ |
| K812760 | HI-TEMP CARDIOVASCULAR CAUTERY | Key Medical, Inc. | 1982-01-18 | Traditional | PDF ↗ |
| K813072 | E2502 & E2502B LECTROSWITCH | Valleylab, Inc. | 1981-11-10 | Traditional | PDF ↗ |
| K813071 | E2508 DISPOSABLE HANDSWITCHING PENCIL | Valleylab, Inc. | 1981-11-10 | Traditional | PDF ↗ |
| K812769 | TRIDENT #2001 | Trident Surgical Corp. | 1981-11-06 | Traditional | PDF ↗ |
| K812722 | SAFE GUARD | Concept, Inc. | 1981-11-05 | Traditional | PDF ↗ |
| K812702 | TECHNICATOR | Cameron-Miller, Inc. | 1981-11-05 | Traditional | PDF ↗ |
| K812637 | ACMI BIPOLAR HEMOSTATIC SOURCE | American Cystocope Makers, Inc. | 1981-10-26 | Traditional | PDF ↗ |
| K812644 | REPLACEABLE BATTERY PERFECTEMP 2 CAUT | Key Medical, Inc. | 1981-10-26 | Traditional | PDF ↗ |
| K812203 | ELECTROSURGICAL UNIT | Reznik Instruments | 1981-10-13 | Traditional | PDF ↗ |
| K812125 | LAPIN CLEAR CUT II | Promed Corp. | 1981-09-24 | Traditional | PDF ↗ |
| K812198 | ACCESSORIES(PROBES, SUCTION TUBES, ETC.) | Reznik Instruments | 1981-09-11 | Traditional | PDF ↗ |
| K811820 | BIPOLAR COAGULATING FORCEPS | New England Surgical Instrument Corp. | 1981-07-28 | Traditional | PDF ↗ |
| K810277 | PREGELLED DISPOS. ELECTROSURG. GROUND EL | Conmedcorp | 1981-03-11 | Traditional | PDF ↗ |
| K810273 | DAVOL ELECTRO MEDICAL SYSTEMS | C.R. Bard, Inc. | 1981-03-04 | Traditional | PDF ↗ |
| K803055 | ELECTROSURGICAL TIP CLEANER & HOLDER | Devon Industries, Inc. | 1981-02-12 | Traditional | PDF ↗ |
| K802942 | HITEMP. TM 2 LOOPTIP CAUTERY | Medical Products Development, Inc. | 1981-02-04 | Traditional | PDF ↗ |
| K810101 | WATER RESISTANT FOOTSWITCH W/CABLE | Aspen Laboratories, Inc. | 1981-01-29 | Traditional | PDF ↗ |
| K802972 | DUAL-TROL | Cimarron Instruments, Inc. | 1981-01-15 | Traditional | PDF ↗ |
| K802827 | BOUIE ELECTROSURGICAL TIP CLEANER | Sybron Corp. | 1980-12-11 | Traditional | PDF ↗ |
| K802605 | ELECTRO SURGICAL TIP CLEANER | Concept, Inc. | 1980-11-12 | Traditional | PDF ↗ |
| K802330 | HI-TEMP LOOPTIP SURGICAL CAUTERY | Medical Products Development, Inc. | 1980-11-12 | Traditional | PDF ↗ |
| K801323 | HI-TEMP SURGICAL CAUTERY | Medical Products Development, Inc. | 1980-06-26 | Traditional | PDF ↗ |
| K801158 | NDM DIATEMP ELECTROSURGICAL DIS. PAD | Ndm Corp. | 1980-05-23 | Traditional | PDF ↗ |
| K801153 | VALLEYLAB RETURN ELECTRODE MONITOR | Valleylab, Inc. | 1980-05-20 | Traditional | PDF ↗ |
| K800617 | HYFRECATOR, #733 | Birtcher Corp. | 1980-05-02 | Traditional | PDF ↗ |
| K800557 | DISPOSABLE PRE-GELLED ELECTROSURGICAL | Vxtra Corp. | 1980-04-21 | Traditional | PDF ↗ |
| K800597 | REUSABLE HAND-TROL | Aspen Laboratories, Inc. | 1980-04-02 | Traditional | PDF ↗ |
| K800317 | DAVOL EMS ADAPTER, CAT. NO. 13-7664 | Electrocaine Medical System | 1980-03-12 | Traditional | PDF ↗ |
| K800022 | MODEL 807 SUCTION CAUTERY FINGER TIP | Malibu Laboratories | 1980-02-11 | Traditional | PDF ↗ |
| K792600 | MODEL III HANDSWITCH | Sara Dan, Inc. | 1980-01-10 | Traditional | PDF ↗ |
| K791868 | OXIMETRIX SHAW HEMOSTATIC SURG. SYS. | Oximetrix, Inc. | 1980-01-04 | Traditional | PDF ↗ |
| K792343 | DIATHERMIC SNARE (CRESENT TYPE) | Mill-Rose Laboratory | 1979-12-18 | Traditional | PDF ↗ |
| K792150 | MODEL 808 ADAPTER | Malibu Laboratories | 1979-12-06 | Traditional | PDF ↗ |
| K792315 | A.D.E. ASPEN DISPERSIVE ELECTRODE | Zimmer, Inc. | 1979-11-27 | Traditional | PDF ↗ |
| K792044 | SAFE RETURN COT. #9675 & CONNECTOR ADAPT | Concept, Inc. | 1979-11-16 | Traditional | PDF ↗ |
| K791541 | EMS ADAPTER MODEL 9160 | Concept, Inc. | 1979-10-22 | Traditional | PDF ↗ |
| K791767 | BOVIE CSV HAND CONTROL ADAPTER | Sybron Corp. | 1979-10-11 | Traditional | PDF ↗ |
| K791415 | MODEL 80-1765 ELECTROSURGICAL UNIT | Cameron-Miller, Inc. | 1979-10-11 | Traditional | PDF ↗ |
| K791752 | LECTROVAC, VALLEYLAB MODELS | Valleylab, Inc. | 1979-10-04 | Traditional | PDF ↗ |
| K791638 | MODEL E2510 SURGISWITCH | Valleylab, Inc. | 1979-09-12 | Traditional | PDF ↗ |
| K791639 | MODEL E2515 ELECTROSURGICAL ACCESSORY | Valleylab, Inc. | 1979-09-12 | Traditional | PDF ↗ |
| K791362 | ELECTROSURGICAL CUT AND COAGU ACCESSORY | Intermedics, Inc. | 1979-09-04 | Traditional | PDF ↗ |
| K791230 | ELECTROSURGICAL GENERATOR (TIM) | Concept, Inc. | 1979-08-16 | Traditional | PDF ↗ |
| K791224 | MALIBU LABS MODEL 800 FINGER TIP CONT | Malibu Laboratories | 1979-08-10 | Traditional | PDF ↗ |
| K791137 | SINGLE USE MONOPOLAR HAND CONTROL PENCIL | Davol, Inc. | 1979-07-24 | Traditional | PDF ↗ |
| K790770 | SAFETY HOLSTER, SINGLE-USE | Aspen Laboratories, Inc. | 1979-05-18 | Traditional | PDF ↗ |
| K790642 | LEY ELECTRO-SURGICAL UNITS | Merced Medical, Inc. | 1979-05-08 | Traditional | PDF ↗ |
| K790296 | ELECTRODE, MODEL E7504 PREP II | Valleylab, Inc. | 1979-04-12 | Traditional | PDF ↗ |
| K790293 | CIMARRON 1000 OR 1000-2 | Cimarron Instruments, Inc. | 1979-04-12 | Traditional | PDF ↗ |
| K790367 | GRAB-IT | Concept, Inc. | 1979-03-02 | Traditional | PDF ↗ |
| K790187 | BOVIE HAND CONTROL | Sybron Corp. | 1979-02-27 | Traditional | PDF ↗ |
| K781799 | EKG, SWITCHING BLADE AND PENS | Bionex, Inc. | 1979-02-26 | Traditional | PDF ↗ |
| K781949 | ELECTROSURGERY MODEL 771 | Birtcher Corp. | 1979-02-26 | Traditional | PDF ↗ |
| K781810 | ELECTROSURGICAL UNIT 3001-3009 | Neomed Corp. | 1978-12-20 | Traditional | PDF ↗ |
| K781511 | LECTROSWITCH MODEL E2502B | Valleylab, Inc. | 1978-10-24 | Traditional | PDF ↗ |
| K781510 | DISPOSABLE LECTROSWITCH, MODEL E2503 | Valleylab, Inc. | 1978-10-24 | Traditional | PDF ↗ |
| K781148 | ELECTROSURGICAL PENCIL SYSTEM | Medical Plastics, Inc. | 1978-08-31 | Traditional | PDF ↗ |
| K781429 | HAND-TROL CONNECTOR EXTENDER | Aspen Laboratories, Inc. | 1978-08-31 | Traditional | PDF ↗ |
| K781101 | ELECTROSURGICAL UNIT 75 | Ritter Co. | 1978-07-17 | Traditional | PDF ↗ |
| K780977 | SINGLE USE BLADE ELECTRODE | Aspen Laboratories, Inc. | 1978-06-22 | Traditional | PDF ↗ |
| K780976 | SINGLE USE BALL ELECTRODE | Aspen Laboratories, Inc. | 1978-06-22 | Traditional | PDF ↗ |
| K780924 | ELECTROSURGICAL GROUNDING PAD CABLE | Johnson & Johnson Professionals, Inc. | 1978-06-22 | Traditional | PDF ↗ |
| K780978 | SINGLE USE ACTIVE ELECTRODE HANDLE | Aspen Laboratories, Inc. | 1978-06-22 | Traditional | PDF ↗ |
| K780975 | SINGLE USE NEEDLE ELECTRODE | Aspen Laboratories, Inc. | 1978-06-22 | Traditional | PDF ↗ |
| K780298 | ELECTRO-SURGICAL GROUNDING PAD | Johnson & Johnson Professionals, Inc. | 1978-02-28 | Traditional | PDF ↗ |
| K780206 | GENERATOR, ELECTROSURGICAL | Valleylab, Inc. | 1978-02-21 | Traditional | PDF ↗ |
| K772199 | CAUTERIES, HOT WIRE, DISP. | Intermedics, Inc. | 1977-12-13 | Traditional | PDF ↗ |
| K772235 | HAND CONTROL ACCESS.-ELECTROSURG. UNITS | Cameron-Miller, Inc. | 1977-12-13 | Traditional | PDF ↗ |
| K771639 | ELECTROSURGICAL GENERATOR | Cameron-Miller, Inc. | 1977-11-29 | Traditional | PDF ↗ |
Product code GEI · Class II · General, Plastic Surgery. Data: openFDA.