CleanCision Wound Retraction and Protection System
K-Number: K172132 · 2017-10-25
ApplicantPrescient Surgical, Inc.
Decision Date2017-10-25
Product CodePQI
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
CleanCision Wound Retraction and Protection System is the device name listed in this FDA 510(k) record. The listed applicant is Prescient Surgical, Inc.. It received FDA 510(k) clearance on 2017-10-25 under 510(k) number K172132. The device is classified under product code PQI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the CleanCision Wound Retraction and Protection System?
CleanCision Wound Retraction and Protection System is a medical device that received FDA 510(k) clearance on 2017-10-25. The listed applicant is Prescient Surgical, Inc.. The 510(k) number is K172132.
When did CleanCision Wound Retraction and Protection System receive FDA 510(k) clearance?
CleanCision Wound Retraction and Protection System received FDA 510(k) clearance on 2017-10-25, under 510(k) number K172132.
Who is the listed applicant for CleanCision Wound Retraction and Protection System?
The FDA 510(k) record lists Prescient Surgical, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for CleanCision Wound Retraction and Protection System?
The FDA product code for CleanCision Wound Retraction and Protection System is PQI.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.