CleanCision Wound Retraction and Protection System— 510(k) K172132

Name: FDA 510(k) clearance K172132
Creator: U.S. Food and Drug Administration
Published: 2017-10-25

Substantially Equivalent

Prescient Surgical, Inc.

FDA 510(k) clearance K172132 for CleanCision Wound Retraction and Protection System, Substantially Equivalent on 2017-10-25. Applicant: Prescient Surgical, Inc.. Device class: 2.

Clearance details

Applicant: Prescient Surgical, Inc.
Product code: Code PQI
Device class: Class 2
Regulation: 21 CFR 878.4371
Advisory panel: General, Plastic Surgery
Date received: 2017-07-14
Decision date: 2017-10-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Carlos, CA, US

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