MCH
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Clip, Hemostatic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4300
- Medical specialty
- General, Plastic Surgery
- Flags
- Implant
- Adverse events (MAUDE)
- 2015: 41 · 2018: 92 · 2019: 77 · 2020: 53 · 2021: 27 · 2022: 125
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| RESOLUTION HEMOSTASIS CLIPPING DEVICE (K040148) | Boston Scientific Corp | 2004-04-22 |
| TITANIUM HEMOSTATIC CLIP (K972745) | Eisner USA, Inc. | 1997-10-21 |
| ATRAUCLIP (TANTALUM HEMOSTATIC CLIP) (K896998) | S.P.K. Technology, Inc. | 1990-06-01 |
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Every clearance here is in the API, with alerts when new ones post.