FDA product code MCH: Clip, Hemostatic
MCH is the FDA product code for clip, hemostatic. It is a Class II device, regulated under 21 CFR 878.4300 and reviewed by the General and Plastic Surgery panel. FDA has cleared 3 510(k) submissions under MCH, from 3 different applicants. The average 510(k) review took 117 days (median 90). FDA has posted 4 recalls for MCH devices.
Classification
| Field | Value |
|---|---|
| Device name | Clip, Hemostatic |
| Device class | Class II |
| Regulation | 21 CFR 878.4300 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Implant | Yes |
Compare with all 510(k) review times · Search every MCH clearance
Top MCH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Boston Scientific Corp | 1 | 2004-04-22 |
| Eisner USA, Inc. | 1 | 1997-10-21 |
| S.P.K. Technology, Inc. | 1 | 1990-06-01 |
Most recent MCH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K040148 | Boston Scientific Corp | RESOLUTION HEMOSTASIS CLIPPING DEVICE | 2004-04-22 | 90 |
| K972745 | Eisner USA, Inc. | TITANIUM HEMOSTATIC CLIP | 1997-10-21 | 90 |
| K896998 | S.P.K. Technology, Inc. | ATRAUCLIP (TANTALUM HEMOSTATIC CLIP) | 1990-06-01 | 171 |
Recalls for MCH devices
4 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2015-12-22.
Frequently asked questions
What is FDA product code MCH?
MCH is the FDA product code for clip, hemostatic. It is a Class II device, regulated under 21 CFR 878.4300 and reviewed by the General and Plastic Surgery panel.
What device class is MCH?
Class II, regulation 21 CFR 878.4300. Typical premarket route: 510(k).
How long does a 510(k) take for product code MCH?
Across 3 cleared submissions the average was 117 days from receipt to decision (median 90).
Which companies have the most MCH clearances?
Boston Scientific Corp (1); Eisner USA, Inc. (1); S.P.K. Technology, Inc. (1).
Have MCH devices been recalled?
Yes: 4 product recalls across 1 recall events; the most recent began 2015-12-22.
Next steps
- Run an FDA pathway report with predicate devices for product code MCH
- Run a recall and safety report across every MCH manufacturer
- Watch product code MCH for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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