FDA product code JOS: Electrode, Electrosurgical
JOS is the FDA product code for electrode, 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 36 510(k) submissions under JOS, from 27 different applicants. The average 510(k) review took 75 days (median 84). FDA has posted 9 recalls for JOS devices.
Classification
| Field | Value |
|---|---|
| Device name | Electrode, 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 JOS clearance
Top JOS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Linvatec Corp. | 3 | 2000-02-10 |
| Aaron Medical Industries | 3 | 1998-06-24 |
| Arthropedics, Inc. | 3 | 1987-12-15 |
| Mist, Inc. | 2 | 1995-06-23 |
| Megadyne Medical Products, Inc. | 2 | 1991-04-12 |
22 more applicants have JOS clearances. See the full list in Caduvo.
Most recent JOS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K161600 | Olympus Winter & Ibe GmbH | Resection Electrodes | 2016-09-06 | 89 |
| K050923 | Conmed Linvatec | LIGHTWAVE INTEGRATED ELECTRODE ABLATOR AND LIGHT WAVE INTEGRATED ELECTRODE SUCTION ABLATOR | 2005-05-18 | 35 |
| K012684 | Sterilmed, Inc. | REPROCESSED ELECTROSURGICAL ELECTRODE | 2002-01-18 | 157 |
| K011515 | Medline Industries, Inc. | MEDLINE GROUNDING PAD | 2001-07-13 | 57 |
| K003403 | Highland / Marietta, Inc. | ENDOSCOPIC MONOPOLAREECTRODE, MODEL EME- 1000 TO 1999 | 2001-05-07 | 187 |
Recalls for JOS devices
9 product recalls in 7 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2019-11-18.
| Year | Recalls |
|---|---|
| 2019 | 2 |
Frequently asked questions
What is FDA product code JOS?
JOS is the FDA product code for electrode, 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 JOS?
Class II, regulation 21 CFR 878.4400. Typical premarket route: 510(k).
How long does a 510(k) take for product code JOS?
Across 36 cleared submissions the average was 75 days from receipt to decision (median 84).
Which companies have the most JOS clearances?
Linvatec Corp. (3); Aaron Medical Industries (3); Arthropedics, Inc. (3); Mist, Inc. (2); Megadyne Medical Products, Inc. (2).
Have JOS devices been recalled?
Yes: 9 product recalls across 7 recall events; the most recent began 2019-11-18.
Next steps
- Run an FDA pathway report with predicate devices for product code JOS
- Run a recall and safety report across every JOS manufacturer
- Watch product code JOS 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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