FDA product code MCA: Tape, Surgical, Internal
MCA is the FDA product code for tape, surgical, internal. It is a Class II device, regulated under 21 CFR 878.3300 and reviewed by the General and Plastic Surgery panel. FDA has cleared 1 510(k) submission under MCA. The average 510(k) review took 61 days (median 61).
Classification
| Field | Value |
|---|---|
| Device name | Tape, Surgical, Internal |
| Device class | Class II |
| Regulation | 21 CFR 878.3300 |
| 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 MCA clearance
Top MCA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| W. L. Gore & Associates, Inc. | 1 | 1990-03-13 |
Most recent MCA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K900195 | W. L. Gore & Associates, Inc. | MODIFIED GORE-TEX SURGICAL TAPE | 1990-03-13 | 61 |
Recalls for MCA devices
openFDA lists no recalls for product code MCA.
Frequently asked questions
What is FDA product code MCA?
MCA is the FDA product code for tape, surgical, internal. It is a Class II device, regulated under 21 CFR 878.3300 and reviewed by the General and Plastic Surgery panel.
What device class is MCA?
Class II, regulation 21 CFR 878.3300. Typical premarket route: 510(k).
How long does a 510(k) take for product code MCA?
Across 1 cleared submissions the average was 61 days from receipt to decision (median 61).
Which companies have the most MCA clearances?
W. L. Gore & Associates, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code MCA
- Run a recall and safety report across every MCA manufacturer
- Watch product code MCA 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.
All General and Plastic Surgery product codes · FDA product code lookup · 510(k) database search · 510(k) review times