FDA product code NXH: Nursing Pad, Cohesive Gel
NXH is the FDA product code for nursing pad, cohesive gel. It is a Class I device, regulated under 21 CFR 880.5630 and reviewed by the General Hospital panel. FDA has cleared 1 510(k) submission under NXH. The average 510(k) review took 121 days (median 121).
Definition
Intended to relieve nipples that are sore and cracked from breast feeding.
Classification
| Field | Value |
|---|---|
| Device name | Nursing Pad, Cohesive Gel |
| Device class | Class I |
| Regulation | 21 CFR 880.5630 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every NXH clearance
Top NXH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Puronxy, Inc. | 1 | 2006-02-09 |
Most recent NXH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K052858 | Puronxy, Inc. | SOOTHIES GEL PADS | 2006-02-09 | 121 |
Recalls for NXH devices
openFDA lists no recalls for product code NXH.
Frequently asked questions
What is FDA product code NXH?
NXH is the FDA product code for nursing pad, cohesive gel. It is a Class I device, regulated under 21 CFR 880.5630 and reviewed by the General Hospital panel.
What device class is NXH?
Class I, regulation 21 CFR 880.5630. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code NXH?
Across 1 cleared submissions the average was 121 days from receipt to decision (median 121).
Which companies have the most NXH clearances?
Puronxy, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NXH
- Run a recall and safety report across every NXH manufacturer
- Watch product code NXH 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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