FDA product code PQI: Wound Retraction And Protection System
PQI is the FDA product code for wound retraction and protection system. It is a Class II device, regulated under 21 CFR 878.4371 and reviewed by the General and Plastic Surgery panel. FDA has cleared 1 510(k) submission under PQI. The average 510(k) review took 103 days (median 103). 1 De Novo request was granted under it.
Definition
A prescription device intended to be used by a surgeon to retract the surgical incision, to provide access to the surgical wound, to protect and irrigate the surgical wound, and to serve as a conduit for removal of fluid from the surgical wound.
Classification
| Field | Value |
|---|---|
| Device name | Wound Retraction And Protection System |
| Device class | Class II |
| Regulation | 21 CFR 878.4371 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for PQI
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 103 |
Compare with all 510(k) review times · Search every PQI clearance
Top PQI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Prescient Surgical, Inc. | 1 | 2017-10-25 |
Most recent PQI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K172132 | Prescient Surgical, Inc. | CleanCision Wound Retraction and Protection System | 2017-10-25 | 103 |
Recalls for PQI devices
openFDA lists no recalls for product code PQI.
Frequently asked questions
What is FDA product code PQI?
PQI is the FDA product code for wound retraction and protection system. It is a Class II device, regulated under 21 CFR 878.4371 and reviewed by the General and Plastic Surgery panel.
What device class is PQI?
Class II, regulation 21 CFR 878.4371. Typical premarket route: 510(k).
How long does a 510(k) take for product code PQI?
Across 1 cleared submissions the average was 103 days from receipt to decision (median 103).
Which companies have the most PQI clearances?
Prescient Surgical, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PQI
- Run a recall and safety report across every PQI manufacturer
- Watch product code PQI 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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