KQMClass I
Camera, Surgical And Accessories
21 CFR 878.4160 / General, Plastic Surgery
KQM is the FDA product code for Camera, Surgical And Accessories, a class I device type, regulated under 21 CFR 878.4160. As of , FDA records hold 18 510(k) clearances under this code, the most recent dated , and 14 recalls.
Classification record
- Product code
- KQM
- Device name
- Camera, Surgical And Accessories
- Regulation
- 21 CFR 878.4160
- Device class
- Class I
- Review panel
- General, Plastic Surgery
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 18
- Ingested recalls
- 14
Clearances, product code KQM
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1981 | 3 |
| 1982 | 1 |
| 1983 | 1 |
| 1984 | 3 |
| 1985 | 1 |
| 1986 | 2 |
| 1987 | 2 |
| 1988 | 3 |
| 1989 | 1 |
| 1990 | 1 |
Applicants with the most clearances
Product code KQM| Applicant | Clearances |
|---|---|
| MEDLINE INDUSTRIES, LP - Northfield | 3 |
| M.P. Video, Inc. | 2 |
| Sony Medical Electronics Co. | 2 |
| Technology for Imaging, Inc. | 2 |
| Concept, Inc. | 1 |
| Hydro-Med Products, Inc. | 1 |
| Janin Group, Inc. | 1 |
| JEDMED Instrument Company | 1 |
| Kamiya Tsusan Kaisha, Ltd. | 1 |
| Sony Corp. of America | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this code- AboCom Systems, Inc.
- Adlink Technology GmbH
- Advanced Product Solutions Inc.
- Aesculap Inc
- Apixia Inc.
- Arspectra SARL
- Arthrex Australia Pty Ltd.
- Arthrex California Technology, Incorporated
- Arthrex Chile SpA
- Arthrex Colombia SAS
- Arthrex Distribution Hub EMEA B.V.
- Arthrex do Brazil Importacao e Comercio de Equipamentos Medicos Ltda
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.
