FDA product code FHR: Needle, Gastro-Urology
FHR is the FDA product code for needle, gastro-urology. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel. FDA has cleared 1 510(k) submission under FHR. The average 510(k) review took 46 days (median 46).
Classification
| Field | Value |
|---|---|
| Device name | Needle, Gastro-Urology |
| Device class | Class I |
| Regulation | 21 CFR 878.4800 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Top FHR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Visitec Co. | 1 | 1981-08-25 |
Most recent FHR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K811965 | Visitec Co. | VISITEC NEEDLE RANGE (GASTERUROLOGY) | 1981-08-25 | 46 |
Recalls for FHR devices
openFDA lists no recalls for product code FHR.
Frequently asked questions
What is FDA product code FHR?
FHR is the FDA product code for needle, gastro-urology. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel.
What device class is FHR?
Class I, regulation 21 CFR 878.4800. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FHR?
Across 1 cleared submissions the average was 46 days from receipt to decision (median 46).
Which companies have the most FHR clearances?
Visitec Co. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FHR
- Run a recall and safety report across every FHR manufacturer
- Watch product code FHR 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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