FDA product code MKY: System, Skin Closure
MKY is the FDA product code for system, skin closure. It is a Class I device, regulated under 21 CFR 878.4320 and reviewed by the General and Plastic Surgery panel. FDA has cleared 6 510(k) submissions under MKY, from 4 different applicants. The average 510(k) review took 133 days (median 119).
Classification
| Field | Value |
|---|---|
| Device name | System, Skin Closure |
| Device class | Class I |
| Regulation | 21 CFR 878.4320 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every MKY clearance
Top MKY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Progressive Surgical Products, Inc. | 3 | 1998-09-08 |
| Wisebands , Ltd. | 1 | 2001-03-15 |
| Phoenix Biomedical Corp. | 1 | 1997-01-14 |
| Life Medical Sciences, Inc. | 1 | 1994-07-19 |
Most recent MKY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K002315 | Wisebands , Ltd. | WISEBANDS SKIN CLOSURE DEVICE | 2001-03-15 | 227 |
| K982439 | Progressive Surgical Products, Inc. | PROXIDERM, MODELS TN 460, TN 90 460, BK 460 | 1998-09-08 | 56 |
| K970439 | Progressive Surgical Products, Inc. | PROXIDERM (D-460,D 90 460,D 180,460, PS 460) | 1997-04-16 | 70 |
| K962144 | Phoenix Biomedical Corp. | PHOENIX ETE TISSUE EXTENSION SYSTEM | 1997-01-14 | 225 |
| K942425 | Progressive Surgical Products, Inc. | PROXIDERM (TENTATIVE) | 1994-11-04 | 168 |
Recalls for MKY devices
openFDA lists no recalls for product code MKY.
Frequently asked questions
What is FDA product code MKY?
MKY is the FDA product code for system, skin closure. It is a Class I device, regulated under 21 CFR 878.4320 and reviewed by the General and Plastic Surgery panel.
What device class is MKY?
Class I, regulation 21 CFR 878.4320. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code MKY?
Across 6 cleared submissions the average was 133 days from receipt to decision (median 119).
Which companies have the most MKY clearances?
Progressive Surgical Products, Inc. (3); Wisebands , Ltd. (1); Phoenix Biomedical Corp. (1); Life Medical Sciences, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code MKY
- Run a recall and safety report across every MKY manufacturer
- Watch product code MKY 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