CleanCisionTM Wound Retraction and Protection System— 510(k) DEN150038

Name: FDA 510(k) clearance DEN150038
Creator: U.S. Food and Drug Administration
Published: 2016-12-16

Unknown

Prescient Surgical

FDA 510(k) clearance DEN150038 for CleanCisionTM Wound Retraction and Protection System, Unknown on 2016-12-16. Applicant: Prescient Surgical. Device class: 2.

Clearance details

Applicant: Prescient Surgical
Product code: Code PQI
Device class: Class 2
Regulation: 21 CFR 878.4371
Advisory panel: General, Plastic Surgery
Date received: 2015-08-13
Decision date: 2016-12-16
Decision: Unknown
Clearance type: Direct
Location: San Carlos, CA, US

View on FDA.gov ↗

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