FDA product code NTC: Nursing Pad, Hydrogel
NTC is the FDA product code for nursing pad, hydrogel. 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 NTC. The average 510(k) review took 613 days (median 613).
Classification
| Field | Value |
|---|---|
| Device name | Nursing Pad, Hydrogel |
| 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 NTC clearance
Top NTC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medtrade Products , Ltd. | 1 | 2004-11-26 |
Most recent NTC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K030901 | Medtrade Products , Ltd. | MEDTRADE PRODICT'S SOOTHING GEL PATCH | 2004-11-26 | 613 |
Recalls for NTC devices
openFDA lists no recalls for product code NTC.
Frequently asked questions
What is FDA product code NTC?
NTC is the FDA product code for nursing pad, hydrogel. It is a Class I device, regulated under 21 CFR 880.5630 and reviewed by the General Hospital panel.
What device class is NTC?
Class I, regulation 21 CFR 880.5630. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code NTC?
Across 1 cleared submissions the average was 613 days from receipt to decision (median 613).
Which companies have the most NTC clearances?
Medtrade Products , Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NTC
- Run a recall and safety report across every NTC manufacturer
- Watch product code NTC 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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