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PQIClass II

Wound Retraction And Protection System

21 CFR 878.4371 / General, Plastic Surgery
FDA source (opens on fda.gov)

PQI is the FDA product code for Wound Retraction And Protection System, a class II device type, regulated under 21 CFR 878.4371. FDA's definition for this code reads: "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". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
PQI
Device name
Wound Retraction And Protection System
FDA 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.
Regulation
21 CFR 878.4371
Device class
Class II
Review panel
General, Plastic Surgery
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
2
Ingested recalls
0

Clearances, product code PQI

By decision year
2 clearances under product code PQI with a decision year between 2016 and 2017, 2016 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PQI by decision year
YearClearances
20161
20171

Applicants with the most clearances

Product code PQI
Applicants holding the most 510(k) clearances under product code PQI
ApplicantClearances
Prescient Surgical2

Companies listing this code with FDA

Companies whose registered establishments list this code