MCHClass II
Clip, Hemostatic
21 CFR 878.4300 / General, Plastic Surgery
MCH is the FDA product code for Clip, Hemostatic, a class II device type, regulated under 21 CFR 878.4300. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and 4 recalls.
Classification record
- Product code
- MCH
- Device name
- Clip, Hemostatic
- Regulation
- 21 CFR 878.4300
- 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
- 3
- Ingested recalls
- 4
Clearances, product code MCH
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1990 | 1 |
| 1997 | 1 |
| 2004 | 1 |
Applicants with the most clearances
Product code MCH| Applicant | Clearances |
|---|---|
| Boston Scientific Corporation | 1 |
| Eisner USA, Inc. | 1 |
| S.P.K. Technology, 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.
