510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN150038Unknown

CleanCisionTM Wound Retraction and Protection System

Prescient Surgical, San Carlos CA / Direct, Unknown
FDA source (opens on fda.gov)

DEN150038 is the FDA 510(k) clearance record for CleanCisionTM Wound Retraction and Protection System, a class II device, cleared for Prescient Surgical on under FDA product code PQI (Wound Retraction And Protection System). FDA's definition for product code PQI 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...". FDA records list 2 510(k) clearances for Prescient Surgical, from to . As of , FDA records show no recalls naming DEN150038.

Clearance record

Decision date
Received
(491 days to decision)
Product code
PQI Wound Retraction And Protection System
Regulation
21 CFR 878.4371
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Prescient Surgical 1585 Industrial Rd., San Carlos CA
Third party review
No

Clearances, product code PQI

Trailing 12 months

FDA records hold no clearances under product code PQI in the trailing twelve months.

FDA records show no clearances under product code PQI in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PQI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260