FDA product code MGQ: Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
MGQ is the FDA product code for dressing, wound and burn, hydrogel w/drug and/or biologic. It is a Unclassified device, reviewed by the General and Plastic Surgery panel. FDA has cleared 145 510(k) submissions under MGQ, from 83 different applicants. The average 510(k) review took 125 days (median 85). FDA has posted 14 recalls for MGQ devices.
Classification
| Field | Value |
|---|---|
| Device name | Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic |
| Device class | Unclassified |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | Unknown |
| Premarket route | 510(k) |
510(k) clearances per year for MGQ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 115 |
Compare with all 510(k) review times · Search every MGQ clearance
Top MGQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Fidia Pharmaceutical Corp. | 10 | 1999-02-10 |
| Brennen Medical, Inc. | 7 | 2000-10-02 |
| Carrington Laboratories, Inc. | 7 | 1996-09-12 |
| Mpm Medical., Inc. | 5 | 1999-12-23 |
| Procyte Corp. | 5 | 1997-06-05 |
78 more applicants have MGQ clearances. See the full list in Caduvo.
Most recent MGQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K171879 | Founders Science Group, LLC | HylaGuard Moisturizing Cream | 2017-10-16 | 115 |
| K083024 | Collegium Pharmaceutical Incorporated | HYLATOPIC EMOLLIENT FOAM | 2009-03-27 | 169 |
| K041342 | Stiefel Laboratories, Inc. | IMPRUV A.I. CREAM WOUND AND SKIN EMULSION | 2005-07-19 | 425 |
| K041268 | Adri | SILVERSITE OR CALGITROL | 2004-09-20 | 131 |
| K040019 | Noble Fiber Technologies | SILVERSEAL | 2004-07-23 | 199 |
Recalls for MGQ devices
14 product recalls in 7 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2017-03-03.
| Year | Recalls |
|---|---|
| 2017 | 1 |
Frequently asked questions
What is FDA product code MGQ?
MGQ is the FDA product code for dressing, wound and burn, hydrogel w/drug and/or biologic. It is a Unclassified device, reviewed by the General and Plastic Surgery panel.
What device class is MGQ?
Unclassified. Typical premarket route: 510(k).
How long does a 510(k) take for product code MGQ?
Across 145 cleared submissions the average was 125 days from receipt to decision (median 85).
Which companies have the most MGQ clearances?
Fidia Pharmaceutical Corp. (10); Brennen Medical, Inc. (7); Carrington Laboratories, Inc. (7); Mpm Medical., Inc. (5); Procyte Corp. (5).
Have MGQ devices been recalled?
Yes: 14 product recalls across 7 recall events; the most recent began 2017-03-03.
Next steps
- Run an FDA pathway report with predicate devices for product code MGQ
- Run a recall and safety report across every MGQ manufacturer
- Watch product code MGQ 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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