FDA product code NAE: Dressing, Wound, Hydrogel Without Drug And/Or Biologic
NAE is the FDA product code for dressing, wound, hydrogel without drug and/or biologic. It is a Class I device, regulated under 21 CFR 878.4022 and reviewed by the General and Plastic Surgery panel. FDA has cleared 29 510(k) submissions under NAE, from 21 different applicants. The average 510(k) review took 110 days (median 89). FDA has posted 6 recalls for NAE devices.
Classification
| Field | Value |
|---|---|
| Device name | Dressing, Wound, Hydrogel Without Drug And/Or Biologic |
| Device class | Class I |
| Regulation | 21 CFR 878.4022 |
| 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 NAE clearance
Top NAE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Brady Medical Products Co. | 4 | 1995-03-01 |
| Smith & Nephew United, Inc. | 3 | 1994-06-29 |
| Gorbec Pharmaceutical Services, Inc. | 2 | 2008-10-23 |
| Ndm Acquisition Corp. | 2 | 1994-02-15 |
| Medtronic Vascular | 2 | 1992-05-28 |
16 more applicants have NAE clearances. See the full list in Caduvo.
Most recent NAE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K083721 | River'S Edge Pharmaceuticals, LLC | MODIFICATION TO ZENIEVA | 2009-01-08 | 24 |
| K082865 | Gorbec Pharmaceutical Services, Inc. | MODIFICATION TO ZENIEVA | 2008-10-23 | 24 |
| K073246 | Gorbec Pharmaceutical Services, Inc. | ZENIEVA | 2008-07-23 | 247 |
| K992094 | Giltech Plus, Inc. | GILTECH PLUS HYDROGEL SKIN DRESSING | 1999-09-17 | 88 |
| K991061 | Dermaphylyx, Inc. | DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING | 1999-06-28 | 90 |
Recalls for NAE devices
6 product recalls in 5 recall events; 0 initiated in the last five years and 1 still open. Most recent: 2020-02-11.
| Year | Recalls |
|---|---|
| 2018 | 2 |
| 2020 | 1 |
Frequently asked questions
What is FDA product code NAE?
NAE is the FDA product code for dressing, wound, hydrogel without drug and/or biologic. It is a Class I device, regulated under 21 CFR 878.4022 and reviewed by the General and Plastic Surgery panel.
What device class is NAE?
Class I, regulation 21 CFR 878.4022. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code NAE?
Across 29 cleared submissions the average was 110 days from receipt to decision (median 89).
Which companies have the most NAE clearances?
Brady Medical Products Co. (4); Smith & Nephew United, Inc. (3); Gorbec Pharmaceutical Services, Inc. (2); Ndm Acquisition Corp. (2); Medtronic Vascular (2).
Have NAE devices been recalled?
Yes: 6 product recalls across 5 recall events; the most recent began 2020-02-11.
Next steps
- Run an FDA pathway report with predicate devices for product code NAE
- Run a recall and safety report across every NAE manufacturer
- Watch product code NAE 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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