FDA product code FHO: Pneumoperitoneum Needle
FHO is the FDA product code for pneumoperitoneum needle. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 15 510(k) submissions under FHO, from 14 different applicants. The average 510(k) review took 114 days (median 56).
Definition
For establishment of a pneumoperitoneum in abdomen.
Classification
| Field | Value |
|---|---|
| Device name | Pneumoperitoneum Needle |
| 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 |
510(k) clearances per year for FHO
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 63 |
Compare with all 510(k) review times · Search every FHO clearance
Top FHO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Origin Medsystems, Inc. | 2 | 1991-11-08 |
| Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd | 1 | 2017-09-14 |
| Vectec | 1 | 2013-08-02 |
| Gibbons Surgical Corp. | 1 | 2001-04-10 |
| Apple Medical Corp. | 1 | 1997-03-27 |
9 more applicants have FHO clearances. See the full list in Caduvo.
Most recent FHO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K172120 | Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd | Veress Needle | 2017-09-14 | 63 |
| K121370 | Vectec | VECTEC DISPOSABLE PNEUMOPERITONEUM NEEDLE | 2013-08-02 | 452 |
| K010779 | Gibbons Surgical Corp. | MODIFICATION TO:LAPAROSCOPIC/ENDOSCOPIC INSTRUMENT | 2001-04-10 | 26 |
| K970788 | Apple Medical Corp. | PNEUMO-MATIC INSUFFLATION NEEDLE | 1997-03-27 | 23 |
| K960574 | Sherwood Medical Co. | ARGYLE TURKEL NEONATAL/PEDIATRIC THORACIC CATHETER INSERTION TRAY AND THORACIC CATHETER SYSTEM | 1996-08-05 | 175 |
Recalls for FHO devices
openFDA lists no recalls for product code FHO.
Frequently asked questions
What is FDA product code FHO?
FHO is the FDA product code for pneumoperitoneum needle. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel.
What device class is FHO?
Class II, regulation 21 CFR 876.1500. Typical premarket route: 510(k).
How long does a 510(k) take for product code FHO?
Across 15 cleared submissions the average was 114 days from receipt to decision (median 56).
Which companies have the most FHO clearances?
Origin Medsystems, Inc. (2); Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd (1); Vectec (1); Gibbons Surgical Corp. (1); Apple Medical Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FHO
- Run a recall and safety report across every FHO manufacturer
- Watch product code FHO 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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