MQRClass II
Stent, Colonic, Metallic, Expandable
21 CFR 878.3610 / General, Plastic Surgery
MQR is the FDA product code for Stent, Colonic, Metallic, Expandable, a class II device type, regulated under 21 CFR 878.3610. As of , FDA records hold 16 510(k) clearances under this code, the most recent dated , and 2 recalls.
Classification record
- Product code
- MQR
- Device name
- Stent, Colonic, Metallic, Expandable
- Regulation
- 21 CFR 878.3610
- Device class
- Class II
- Review panel
- General, Plastic Surgery
- Submission type
- 510(k)
- Implant
- Yes
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 16
- Ingested recalls
- 2
Clearances, product code MQR
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1996 | 1 |
| 1999 | 1 |
| 2000 | 3 |
| 2003 | 1 |
| 2004 | 1 |
| 2006 | 2 |
| 2012 | 1 |
| 2018 | 1 |
| 2019 | 2 |
| 2020 | 2 |
| 2024 | 1 |
Applicants with the most clearances
Product code MQR| Applicant | Clearances |
|---|---|
| Boston Scientific Corporation | 10 |
| M.I.Tech Co Ltd | 3 |
| C.R. Bard Inc | 1 |
| Cook Ireland Ltd. | 1 |
| Med Institute, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
