CleanCision Wound Retraction and Protection System

FDA UDI

Class II (US FDA UDI)

by Prescient Surgical, Inc.

Identity

Trade Name: CleanCision Wound Retraction and Protection System FDA UDI
Generic Name: Radial surgical retractor FDA UDI
Device Name: The CleanCision Wound Retraction and Protection System is a sterile, single-use device, which integrates controlled fluid delivery, wound barrier protection and surgical retraction. FDA UDI
Model / Reference: FG 0002 FDA UDI
Description: The CleanCision Wound Retraction and Protection System is a sterile, single-use device, which integrates controlled fluid delivery, wound barrier protection and surgical retraction. FDA UDI

Identifiers

Catalog Number: CC-M FDA UDI
Primary DI / UDI-DI: 00868532000321 FDA UDI
510(k) Number: K172132 FDA UDI
FDA Product Code: PQI FDA UDI
GMDN Term: Radial surgical retractor FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4371 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Ethylene Oxide FDA UDI

Category: Radial surgical retractor

CleanCision Wound Retraction and Protection System by Prescient Surgical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Radial surgical retractor.

Medline — MEDLINE INDUSTRIES, INC. · Class I
4CIS® Riviera Disposable Retractor System — ALPHANOX CO., LTD. · Class I
EZ Access™ — VLV ASSOCIATES, INC. · Class II
Alexis® Orthopaedic Protector — APPLIED MEDICAL RESOURCES CORP. · Class II
Alexis Wound Protector-Retractor — APPLIED MEDICAL RESOURCES CORP. · Class II
Alexis Wound Protector-Retractor — APPLIED MEDICAL RESOURCES CORP. · Class II
Medline — MEDLINE INDUSTRIES, INC. · Class I
Alexis ® O C-Section Protector - Retractor — APPLIED MEDICAL RESOURCES CORP. · Class II

Cleared under the same submission

K172132 also covers:

CleanCision™ Wound Retraction and Protection System — Prescient Surgical, Inc.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Prescient Surgical, Inc.

Sources (1)

FDA UDI f8a313f5-a17e-4de9-9783-b45dc86de6cf 38 fields · synced May 30, 2026