JOS · Electrode, Electrosurgical
General, Plastic Surgery · 21 CFR 878.4400 · Class 2
Overview
| Product Code | JOS |
|---|---|
| Device Name | Electrode, Electrosurgical |
| Regulation | 21 CFR 878.4400 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
| 3rd-Party Reviewable | Yes |
Identification
An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.
Classification Rationale
Class II.
Cleared Devices (36)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K161600 | Resection Electrodes | Olympus Winter & Ibe GmbH | Sep 6, 2016 | SESE |
| K050923 | LIGHTWAVE INTEGRATED ELECTRODE ABLATOR AND LIGHT WAVE INTEGRATED ELECTRODE SUCTION ABLATOR | Conmed Linvatec | May 18, 2005 | SESE |
| K012684 | REPROCESSED ELECTROSURGICAL ELECTRODE | Sterilmed, Inc. | Jan 18, 2002 | SESE |
| K011515 | MEDLINE GROUNDING PAD | Medline Industries, Inc. | Jul 13, 2001 | SESE |
| K003403 | ENDOSCOPIC MONOPOLAREECTRODE, MODEL EME- 1000 TO 1999 | Highland / Marietta, Inc. | May 7, 2001 | SESE |
| K000333 | STANDARD & EXTENDED BLADE, STANDARD & EXTENDED NEEDLE, STANDARD & EXTENDED BALL, MODIFIED STANDARD & EXTENDED BLADE, MOD | Triad Surgical Technologies, Inc. | May 3, 2000 | SESE |
| K993885 | ULTRABLATOR ELECTRODE | Linvatec Corp. | Feb 10, 2000 | SESE |
| K991830 | CAPSULAR SHRINKAGE ELECTRODE | Linvatec Corp. | Aug 20, 1999 | SESE |
| K974735 | STANDARD AND EXTENDED BLADE, NEEDLE AND BALL; MODIFIED STANDARD AND EXTENDED BLADE & NEEDLE; STANDARD 45 DEGREE BLADE | Aaron Medical Industries | Jun 24, 1998 | SESE |
| K973554 | VALLEY FORGE BIPOLAR BALL TIP ELECTRODE | Valley Forge Scientific Corp. | Dec 19, 1997 | SESE |
| K971187 | STANDARD & EXTENDED BLADE/NEEDLE/BALL;MODIFIED STANDARD & EXTENDED BLADE/NEEDLE | Aaron Medical Industries | May 5, 1997 | SESE |
| K962544 | MICRO DIAMOND-POINT DISSECTION NEEDLES | Dsp Worldwide | Sep 20, 1996 | SESE |
| K962313 | MODIFIED LEVEEN NEEDLE ELECTRODE | Radiotherapeutics Corp. | Sep 11, 1996 | SESE |
| K955636 | SENTRY DISPOSABLE DISPERSIVE ELECTRODE | Sentry Medical Products, Inc. | Mar 27, 1996 | SESE |
| K952323 | MIST ELECTROSURGICAL PROBES, VARIOUS STYLES & SIZES | Mist, Inc. | Jun 23, 1995 | SESE |
| K952290 | MIST ELECTROSURGICAL PROBES, VARIOUS STYLES & SIZES, SURGICAL INSTRUMENTS USED DURING ENDOSCOPIC PROCEDURES | Mist, Inc. | Jun 23, 1995 | SESE |
| K950455 | DEVICE, ELECTROSURGICAL, CUTTING AND COAGULATION & ACCESSORIES | Aaron Medical Industries | May 16, 1995 | SESE |
| K944992 | ELECTRODES | Linvatec Corp. | Apr 27, 1995 | SESE |
| K923037 | MILES SODIUM METHOD | Heraeus Kulzer, Inc. | Sep 22, 1992 | SESE |
| K905060 | ELECTRODE EXTENDER | Megadyne Medical Products, Inc. | Apr 12, 1991 | SESE |
| K903302 | ELECTRODE, ELECTROSURGERY | Megadyne Medical Products, Inc. | Oct 2, 1990 | SESE |
| K895331 | ELECTROSURGICAL ELECTRODE | New England Surgical Instrument Corp. | Sep 15, 1989 | SESE |
| K891400 | MICRO CAUTERY NEEDLES | Zinnanti Surgical Instruments, Inc. | Apr 6, 1989 | SESE |
| K890973 | STRAIGHT PADDLE SURGICAL CAUTERY ELECTRODE BLADE | Instrument Makar, Inc. | Mar 22, 1989 | SESE |
| K890972 | HOOK TIP SURGICAL CAUTERY ELECTRODE BLADE | Instrument Makar, Inc. | Mar 22, 1989 | SESE |
| K882421 | INFANT ELECTROSURGICAL DISPERSIVE ELECTRODE | Dermacare Products, Inc. | Jun 30, 1988 | SESE |
| K881763 | COLORADO NEEDLE ELECTRODE | Colorado Biomedical, Inc. | Jun 20, 1988 | SESE |
| K881144 | YESNG PATIENT PLATE #80226 | Ferguson Medical | Apr 8, 1988 | SESE |
| K874719 | STRATUM ESU | Alternative Design Systems, Inc. | Feb 16, 1988 | SESE |
| K873655 | MONOPOLAR CAUTERY RETROGADE TIP #TM-1703 | Arthropedics, Inc. | Dec 15, 1987 | SESE |
| K873654 | MONOPOLAR CAUTERY CONICAL TIP #TM-1702 | Arthropedics, Inc. | Dec 15, 1987 | SESE |
| K873653 | MONOPOLAR CAUTERY BLADE TIP #TM-1701 | Arthropedics, Inc. | Dec 15, 1987 | SESE |
| K810628 | ELECTROSURGICAL CUTTING & COAGULATION | Intermedics, Inc. | Apr 3, 1981 | SESE |
| K792365 | BIPOLAR FORCEPS | Concept, Inc. | Dec 10, 1979 | SESE |
| K780405 | INFANT ELECTROSURGICAL GROUNDING PAD | New Dimensions IN Medicine, Inc. | Apr 5, 1978 | SESE |
| K772160 | ELECTROSURGICAL GROUNDING PAD | Ndm Corp. | Nov 28, 1977 | SESE |
Top Applicants
- Linvatec Corp. — 3 clearances
- Arthropedics, Inc. — 3 clearances
- Aaron Medical Industries — 3 clearances
- Mist, Inc. — 2 clearances
- Megadyne Medical Products, Inc. — 2 clearances
