Sterilized Omni Gel
FDA 510(k) K872519 · Echo Ultrasound
510(k) numberK872519
Submission
- Device name
- Sterilized Omni Gel
- Applicant
- Echo Ultrasound
Lewistown, PA, US - Received
- June 25, 1987
- Decision date
- August 3, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|---|
| K923647 | Rfg-Dgp Disposable Grounding PadsJOT · Traditional | Radionics, Inc. | 11/09/1992SE |
| 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 |
| 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 |
|---|---|---|
| K924054 | PhonocardiographDQC · Traditional | 01/22/1993SE |
| K903414 | Transesophageal Probe Holder & Disinfecting ColumnDXK · Traditional | 09/19/1990SE |
| K893225 | Couplant Warming DeviceIYO · Traditional | 10/12/1989SE |
| K844120 | Ultrasonic Scanner Calibration & Test ObjectsGXX · Traditional | 01/23/1985SE |
| K844034 | SonocareDYO · Traditional | 01/23/1985SE |
Questions and answers
When was Sterilized Omni Gel cleared by the FDA?
Sterilized Omni Gel (K872519) received a 510(k) decision of Substantially Equivalent on August 3, 1987, 39 days after the submission was received.
What is the product code of K872519?
The FDA product code is JOT – Electrode, Gel, Electrosurgical, a Class II (moderate risk) device regulated under 21 CFR 878.4400.