FDA product code FDP: Apparatus, Pneumoperitoneum, Automatic
FDP is the FDA product code for apparatus, pneumoperitoneum, automatic. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the General and Plastic Surgery panel. FDA has cleared 1 510(k) submission under FDP. The average 510(k) review took 18 days (median 18).
Classification
| Field | Value |
|---|---|
| Device name | Apparatus, Pneumoperitoneum, Automatic |
| Device class | Class II |
| Regulation | 21 CFR 876.1500 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every FDP clearance
Top FDP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| ETHICON, Inc. | 1 | 1991-03-19 |
Most recent FDP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K910875 | ETHICON, Inc. | ENDOPATH DISPOSABLE PNEUMOPERITONEUM NEEDLE | 1991-03-19 | 18 |
Recalls for FDP devices
openFDA lists no recalls for product code FDP.
Frequently asked questions
What is FDA product code FDP?
FDP is the FDA product code for apparatus, pneumoperitoneum, automatic. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the General and Plastic Surgery panel.
What device class is FDP?
Class II, regulation 21 CFR 876.1500. Typical premarket route: 510(k).
How long does a 510(k) take for product code FDP?
Across 1 cleared submissions the average was 18 days from receipt to decision (median 18).
Which companies have the most FDP clearances?
ETHICON, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FDP
- Run a recall and safety report across every FDP manufacturer
- Watch product code FDP 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