Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

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 a medical device manufactured by Prescient Surgical, Inc.. It received FDA 510(k) clearance on 2017-10-25 under approval 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. It is manufactured by Prescient Surgical, Inc.. The 510(k) number is K172132.

When was CleanCision Wound Retraction and Protection System approved by the FDA?

CleanCision Wound Retraction and Protection System received FDA 510(k) clearance on 2017-10-25, under approval number K172132.

What company makes CleanCision Wound Retraction and Protection System?

CleanCision Wound Retraction and Protection System is manufactured by Prescient Surgical, Inc..

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.

Related Clinical Trials

NCT07613892 Post Operative Skin Approximation With Cyanoacrylate Based Wound Closure Adhesives COMPLETED NCT07370051 Effect of Topical Oxygen and LED Light Therapy on Nipple Crack NOT_YET_RECRUITING NCT07607366 Effects of Negative Pressure Wound Bandaging After Mastectomy RECRUITING NCT07489820 Evaluation of the Efficacy of Negative Pressure Wound Therapy on Perineal Healing Following Abdominoperineal Amputation NOT_YET_RECRUITING NCT07600489 A Randomized Non-Inferiority Study of Mepi™ Press 2 vs UrgoK2® for Compression Therapy in Venous Leg Ulcers NOT_YET_RECRUITING NCT07276711 CAPTURE-2: Controlled Arterial Protection to Ultimately Remove Embolic Material RECRUITING

Related PubMed Literature

PMID: 41516911 Substance-Based Medical Device in Wound Care: Bridging Regulatory Clarity and Therapeutic Innovation. Polymers (2025) PMID: 40624966 Peptide-Enhanced Bioactive Hydrogel Combined with Photodynamic-Phage Synergistic Antibacterial Therapy System Accelerates Infected Wound Healing. Advanced healthcare materials (2025)

Related Devices (Code: PQI)

DEN150038CleanCisionTM Wound Retraction and Protection SystemPrescient Surgical

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.

↑