FDA product code MIC: Implant, Muscle, Pectoralis
MIC is the FDA product code for implant, muscle, pectoralis. It is a Class II device, regulated under 21 CFR 874.3620 and reviewed by the General and Plastic Surgery panel. FDA has cleared 8 510(k) submissions under MIC, from 7 different applicants. The average 510(k) review took 75 days (median 70). FDA has posted 1 recall for MIC devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Implant, Muscle, Pectoralis |
| Device class | Class II |
| Regulation | 21 CFR 874.3620 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) |
| Implant | Yes |
Compare with all 510(k) review times · Search every MIC clearance
Top MIC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Seare Biomedical Corp. | 2 | 1998-09-30 |
| Aesthetic and Reconstructive Technologies, Inc. | 1 | 2002-07-03 |
| Pillar Surgical, Inc. | 1 | 2000-11-21 |
| Hanson Medical, Inc. | 1 | 1997-12-24 |
| Rand Scientific Corp. | 1 | 1996-04-19 |
2 more applicants have MIC clearances. See the full list in Caduvo.
Most recent MIC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K021337 | Aesthetic and Reconstructive Technologies, Inc. | AART PECTORALIS IMPLANT | 2002-07-03 | 68 |
| K002633 | Pillar Surgical, Inc. | SILMAX PECTORAL IMPLANT | 2000-11-21 | 90 |
| K982762 | Seare Biomedical Corp. | SEARE BIOMEDICAL PECTORALIS IMPLANT | 1998-09-30 | 55 |
| K983043 | Seare Biomedical Corp. | SEARE BIOMEDICAL SILICONE BLOCK | 1998-09-30 | 30 |
| K973729 | Hanson Medical, Inc. | POWERFLEX PEC IMPLANT | 1997-12-24 | 85 |
Recalls for MIC devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2025-09-26.
| Year | Recalls |
|---|---|
| 2025 | 1 |
Frequently asked questions
What is FDA product code MIC?
MIC is the FDA product code for implant, muscle, pectoralis. It is a Class II device, regulated under 21 CFR 874.3620 and reviewed by the General and Plastic Surgery panel.
What device class is MIC?
Class II, regulation 21 CFR 874.3620. Typical premarket route: 510(k).
How long does a 510(k) take for product code MIC?
Across 8 cleared submissions the average was 75 days from receipt to decision (median 70).
Which companies have the most MIC clearances?
Seare Biomedical Corp. (2); Aesthetic and Reconstructive Technologies, Inc. (1); Pillar Surgical, Inc. (1); Hanson Medical, Inc. (1); Rand Scientific Corp. (1).
Have MIC devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2025-09-26.
Next steps
- Run an FDA pathway report with predicate devices for product code MIC
- Run a recall and safety report across every MIC manufacturer
- Watch product code MIC 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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