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.
Recent Cleared Devices (20 of 36)
Showing 20 most recent of 36 cleared devices.
| 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 |
Top Applicants
- Aaron Medical Industries — 3 clearances
- Arthropedics, Inc. — 3 clearances
- Linvatec Corp. — 3 clearances
- Instrument Makar, Inc. — 2 clearances
- Megadyne Medical Products, Inc. — 2 clearances
