FDA product code MGP: Dressing, Wound And Burn, Occlusive
MGP is the FDA product code for dressing, wound and burn, occlusive. It is a Unclassified device, reviewed by the General and Plastic Surgery panel. FDA has cleared 80 510(k) submissions under MGP, from 55 different applicants. The average 510(k) review took 103 days (median 72). FDA has posted 1 recall for MGP devices.
Classification
| Field | Value |
|---|---|
| Device name | Dressing, Wound And Burn, Occlusive |
| Device class | Unclassified |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | Unknown |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every MGP clearance
Top MGP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Polymedica Industries, Inc. | 6 | 1997-10-24 |
| Acutek Adhesive Specialties, Inc. | 4 | 1998-10-21 |
| Dermaphylyx, Inc. | 3 | 1999-09-14 |
| Innovative Technologies , Ltd. | 3 | 1998-12-09 |
| Bioderm, Inc. | 3 | 1998-10-13 |
50 more applicants have MGP clearances. See the full list in Caduvo.
Most recent MGP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K012997 | Biocore Medical Technologies, Inc. | COLLATEK FOAM | 2001-10-25 | 49 |
| K012995 | Biocore Medical Technologies, Inc. | COLLATEK SHEET | 2001-10-25 | 49 |
| K001508 | Fidia Advanced Biopolymers Srl | LASERSKIN DRESSING | 2001-07-25 | 436 |
| K990079 | Greenfield Medical Technologies, Inc. | FASTSEAL CHEST WOUND DRESSING | 1999-12-23 | 346 |
| K991214 | Hollister, Inc. | SIMPLICARE TRANSPARENT WOUND DRESSING | 1999-10-14 | 188 |
Recalls for MGP devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2011-02-11.
Frequently asked questions
What is FDA product code MGP?
MGP is the FDA product code for dressing, wound and burn, occlusive. It is a Unclassified device, reviewed by the General and Plastic Surgery panel.
What device class is MGP?
Unclassified. Typical premarket route: 510(k).
How long does a 510(k) take for product code MGP?
Across 80 cleared submissions the average was 103 days from receipt to decision (median 72).
Which companies have the most MGP clearances?
Polymedica Industries, Inc. (6); Acutek Adhesive Specialties, Inc. (4); Dermaphylyx, Inc. (3); Innovative Technologies , Ltd. (3); Bioderm, Inc. (3).
Have MGP devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2011-02-11.
Next steps
- Run an FDA pathway report with predicate devices for product code MGP
- Run a recall and safety report across every MGP manufacturer
- Watch product code MGP 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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