FDA product code NEH: Anchor, Fascial
NEH is the FDA product code for anchor, fascial. It is a Class II device, regulated under 21 CFR 878.4300 and reviewed by the General and Plastic Surgery panel. FDA has cleared 1 510(k) submission under NEH. The average 510(k) review took 55 days (median 55).
Classification
| Field | Value |
|---|---|
| Device name | Anchor, Fascial |
| Device class | Class II |
| Regulation | 21 CFR 878.4300 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Implant | Yes |
Compare with all 510(k) review times · Search every NEH clearance
Top NEH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| American Medical Systems, Inc. | 1 | 2001-03-26 |
Most recent NEH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K010277 | American Medical Systems, Inc. | AMS FASCIAL-ANCHORING SYSTEM | 2001-03-26 | 55 |
Recalls for NEH devices
openFDA lists no recalls for product code NEH.
Frequently asked questions
What is FDA product code NEH?
NEH is the FDA product code for anchor, fascial. It is a Class II device, regulated under 21 CFR 878.4300 and reviewed by the General and Plastic Surgery panel.
What device class is NEH?
Class II, regulation 21 CFR 878.4300. Typical premarket route: 510(k).
How long does a 510(k) take for product code NEH?
Across 1 cleared submissions the average was 55 days from receipt to decision (median 55).
Which companies have the most NEH clearances?
American Medical Systems, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NEH
- Run a recall and safety report across every NEH manufacturer
- Watch product code NEH 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