FDA product code FHP: Needle, Pneumoperitoneum, Simple
FHP is the FDA product code for needle, pneumoperitoneum, simple. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 2 510(k) submissions under FHP, from 2 different applicants. The average 510(k) review took 41 days (median 41).
Classification
| Field | Value |
|---|---|
| Device name | Needle, Pneumoperitoneum, Simple |
| Device class | Class II |
| Regulation | 21 CFR 876.1500 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every FHP clearance
Top FHP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Symbiosis Corp. | 1 | 1991-04-18 |
| Endotherapeutics | 1 | 1986-02-12 |
Most recent FHP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K910855 | Symbiosis Corp. | ENDOPATH VERESS NEEDLE | 1991-04-18 | 49 |
| K860102 | Endotherapeutics | MOD. ENDONEEDLE SINGLE-USE PNEUMOPERITONEUM NEEDLE | 1986-02-12 | 33 |
Recalls for FHP devices
openFDA lists no recalls for product code FHP.
Frequently asked questions
What is FDA product code FHP?
FHP is the FDA product code for needle, pneumoperitoneum, simple. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel.
What device class is FHP?
Class II, regulation 21 CFR 876.1500. Typical premarket route: 510(k).
How long does a 510(k) take for product code FHP?
Across 2 cleared submissions the average was 41 days from receipt to decision (median 41).
Which companies have the most FHP clearances?
Symbiosis Corp. (1); Endotherapeutics (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FHP
- Run a recall and safety report across every FHP manufacturer
- Watch product code FHP 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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