JOT · Electrode, Gel, Electrosurgical
General, Plastic Surgery · 21 CFR 878.4400 · Class 2
Overview
| Product Code | JOT |
|---|---|
| Device Name | Electrode, Gel, 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 (9 of 9)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K923647 | RFG-DGP DISPOSABLE GROUNDING PADS | Radionics, Inc. | Nov 9, 1992 | SESE |
| K905545 | ULTRASOUND TRANSMISSION GEL | Arbo Medical, Inc. | Mar 29, 1991 | SESE |
| K904418 | ULTRASOUND COUPLING GEL | Geno Laboratories | Feb 11, 1991 | SESE |
| K901217 | TRIA-SONIC ULTRA SOUND TRANSMISSION GEL | H & P Industries, Inc. | Jun 22, 1990 | SESE |
| K894490 | STERILE ULTRASOUND TRANSMISSION GEL | Swedish Trade Council USA | Oct 5, 1989 | SESE |
| K884503 | ULTRASONIC TRANSMISSION GEL | Herbert Stanley Co. | Feb 13, 1989 | SESE |
| K872519 | STERILIZED OMNI GEL | Echo Ultrasound | Aug 3, 1987 | SESE |
| K871565 | ULTRASOUND TRANSDUCER GEL, STERILE | Amedic USA | Jul 15, 1987 | SESE |
| K800933 | R2 ELECTROSURG. RETURN ELECT. #225ETC. | R2 Corp. | May 20, 1980 | SESE |
Top Applicants
- Amedic USA — 1 clearance
- Arbo Medical, Inc. — 1 clearance
- Echo Ultrasound — 1 clearance
- Geno Laboratories — 1 clearance
- H & P Industries, Inc. — 1 clearance
