Rfg-Dgp Disposable Grounding Pads
FDA 510(k) K923647 · Radionics, Inc.
510(k) numberK923647
Submission
- Device name
- Rfg-Dgp Disposable Grounding Pads
- Applicant
- Radionics, Inc.
Burlington, MA, US - Received
- July 21, 1992
- Decision date
- November 9, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JOT – Electrode, Gel, Electrosurgical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4400
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code JOT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K905545 | Ultrasound Transmission GelJOT · Traditional | Arbo Medical, Inc. | 03/29/1991SE |
| K904418 | Ultrasound Coupling GelJOT · Traditional | Geno Laboratories | 02/11/1991SE |
| K901217 | Tria-Sonic Ultra Sound Transmission GelJOT · Traditional | H & P Industries, Inc. | 06/22/1990SE |
| K894490 | Sterile Ultrasound Transmission GelJOT · Traditional | Swedish Trade Council USA | 10/05/1989SE |
| K884503 | Ultrasonic Transmission GelJOT · Traditional | Herbert Stanley Co. | 02/13/1989SE |
| K872519 | Sterilized Omni GelJOT · Traditional | Echo Ultrasound | 08/03/1987SE |
| K871565 | Ultrasound Transducer Gel, SterileJOT · Traditional | Amedic USA | 07/15/1987SE |
| K800933 | R2 Electrosurg. Return Elect. #225ETC.JOT · Traditional | R2 Corp. | 05/20/1980SE |
More from R2 Corp.
| 510(k) | Device | Decision |
|---|---|---|
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| K992226 | XDS External CSF Drainage and Monitoring SystemJXG · Traditional | 08/04/2000SE |
| K001950 | Optical Tracking System (Ots)HAW · Special | 07/26/2000SE |
| K001700 | Xplan 2.1MUJ · Special | 06/28/2000SE |
| K001431 | Modification to Optical Tracking System (Ots)HAW · Special | 05/17/2000SE |
| K000057 | Radionics Lumboperitoneal ShuntJXG · Traditional | 03/20/2000SE |
| K993594 | Conformax MMLC VR1IYE · Special | 12/15/1999SE |
| K991399 | Radionics Microelectrode KitGXI · Traditional | 09/21/1999SE |
Questions and answers
When was Rfg-Dgp Disposable Grounding Pads cleared by the FDA?
Rfg-Dgp Disposable Grounding Pads (K923647) received a 510(k) decision of Substantially Equivalent on November 9, 1992, 111 days after the submission was received.
What is the product code of K923647?
The FDA product code is JOT – Electrode, Gel, Electrosurgical, a Class II (moderate risk) device regulated under 21 CFR 878.4400.