FDA product code JOT: Electrode, Gel, Electrosurgical
JOT is the FDA product code for electrode, gel, electrosurgical. It is a Class II device, regulated under 21 CFR 878.4400 and reviewed by the General and Plastic Surgery panel. FDA has cleared 9 510(k) submissions under JOT, from 9 different applicants. The average 510(k) review took 89 days (median 101).
Classification
| Field | Value |
|---|---|
| Device name | Electrode, Gel, Electrosurgical |
| Device class | Class II |
| Regulation | 21 CFR 878.4400 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every JOT clearance
Top JOT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Radionics, Inc. | 1 | 1992-11-09 |
| Arbo Medical, Inc. | 1 | 1991-03-29 |
| Geno Laboratories | 1 | 1991-02-11 |
| H & P Industries, Inc. | 1 | 1990-06-22 |
| Swedish Trade Council USA | 1 | 1989-10-05 |
4 more applicants have JOT clearances. See the full list in Caduvo.
Most recent JOT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K923647 | Radionics, Inc. | RFG-DGP DISPOSABLE GROUNDING PADS | 1992-11-09 | 111 |
| K905545 | Arbo Medical, Inc. | ULTRASOUND TRANSMISSION GEL | 1991-03-29 | 108 |
| K904418 | Geno Laboratories | ULTRASOUND COUPLING GEL | 1991-02-11 | 137 |
| K901217 | H & P Industries, Inc. | TRIA-SONIC ULTRA SOUND TRANSMISSION GEL | 1990-06-22 | 101 |
| K894490 | Swedish Trade Council USA | STERILE ULTRASOUND TRANSMISSION GEL | 1989-10-05 | 79 |
Recalls for JOT devices
openFDA lists no recalls for product code JOT.
Frequently asked questions
What is FDA product code JOT?
JOT is the FDA product code for electrode, gel, electrosurgical. It is a Class II device, regulated under 21 CFR 878.4400 and reviewed by the General and Plastic Surgery panel.
What device class is JOT?
Class II, regulation 21 CFR 878.4400. Typical premarket route: 510(k).
How long does a 510(k) take for product code JOT?
Across 9 cleared submissions the average was 89 days from receipt to decision (median 101).
Which companies have the most JOT clearances?
Radionics, Inc. (1); Arbo Medical, Inc. (1); Geno Laboratories (1); H & P Industries, Inc. (1); Swedish Trade Council USA (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JOT
- Run a recall and safety report across every JOT manufacturer
- Watch product code JOT for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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