JOSClass II
Electrode, Electrosurgical
21 CFR 878.4400 / General, Plastic Surgery
JOS is the FDA product code for Electrode, Electrosurgical, a class II device type, regulated under 21 CFR 878.4400. As of , FDA records hold 36 510(k) clearances under this code, the most recent dated , and 9 recalls.
Classification record
- Product code
- JOS
- Device name
- Electrode, Electrosurgical
- Regulation
- 21 CFR 878.4400
- Device class
- Class II
- Review panel
- General, Plastic Surgery
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 36
- Ingested recalls
- 9
Clearances, product code JOS
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1977 | 1 |
| 1978 | 1 |
| 1979 | 1 |
| 1981 | 1 |
| 1987 | 3 |
| 1988 | 4 |
| 1989 | 4 |
| 1990 | 1 |
| 1991 | 1 |
| 1992 | 1 |
| 1995 | 4 |
| 1996 | 3 |
| 1997 | 2 |
| 1998 | 1 |
| 1999 | 1 |
| 2000 | 2 |
| 2001 | 2 |
| 2002 | 1 |
| 2005 | 1 |
| 2016 | 1 |
Applicants with the most clearances
Product code JOS| Applicant | Clearances |
|---|---|
| Apyx Medical Corporation | 3 |
| Arthropedics, Inc. | 3 |
| Linvatec Corporation | 3 |
| Instrument Makar, Inc. | 2 |
| Megadyne Medical Products, Inc | 2 |
| Mist, Inc. | 2 |
| Alternative Design Systems, Inc. | 1 |
| Colorado Biomedical, Inc. | 1 |
| Concept, Inc. | 1 |
| Conmed Linvatec | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this code- Accurate Surgical & Scientific Instruments Corp.
- Arvato SE
- CBR Enterprise Limited
- ConMed Corporation
- Consolidated Medical Equipment Company
- Custom Manufacturing Inc.
- Cynosure, LLC
- ERBE Elektromedizin GmbH
- Gyrus ACMI, Inc.
- International Sterilization Laboratory, LLC
- Isomedix Operations Inc
- Karl Storz Endoscopy Canada Ltd.
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
