Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart E — Surgical Devices](/submissions/SU/subpart-e%E2%80%94surgical-devices) → [21 CFR 878.4400](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4400) → JOT — Electrode, Gel, Electrosurgical

# JOT · Electrode, Gel, Electrosurgical

_General, Plastic Surgery · 21 CFR 878.4400 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/JOT

## Overview

- **Product Code:** JOT
- **Device Name:** Electrode, Gel, Electrosurgical
- **Regulation:** [21 CFR 878.4400](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4400)
- **Device Class:** 2
- **Review Panel:** [General, Plastic Surgery](/submissions/SU)
- **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](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/JOT/K923647.md) | RFG-DGP DISPOSABLE GROUNDING PADS | Radionics, Inc. | Nov 9, 1992 | SESE |
| [K905545](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/JOT/K905545.md) | ULTRASOUND TRANSMISSION GEL | Arbo Medical, Inc. | Mar 29, 1991 | SESE |
| [K904418](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/JOT/K904418.md) | ULTRASOUND COUPLING GEL | Geno Laboratories | Feb 11, 1991 | SESE |
| [K901217](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/JOT/K901217.md) | TRIA-SONIC ULTRA SOUND TRANSMISSION GEL | H & P Industries, Inc. | Jun 22, 1990 | SESE |
| [K894490](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/JOT/K894490.md) | STERILE ULTRASOUND TRANSMISSION GEL | Swedish Trade Council USA | Oct 5, 1989 | SESE |
| [K884503](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/JOT/K884503.md) | ULTRASONIC TRANSMISSION GEL | Herbert Stanley Co. | Feb 13, 1989 | SESE |
| [K872519](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/JOT/K872519.md) | STERILIZED OMNI GEL | Echo Ultrasound | Aug 3, 1987 | SESE |
| [K871565](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/JOT/K871565.md) | ULTRASOUND TRANSDUCER GEL, STERILE | Amedic USA | Jul 15, 1987 | SESE |
| [K800933](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/JOT/K800933.md) | 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

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**Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/JOT](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/JOT)

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