CleanCision Wound Retraction And Protection System

Wound Retraction And Protection System

Prescient Surgical, Inc.

The following data is part of a premarket notification filed by Prescient Surgical, Inc. with the FDA for Cleancision Wound Retraction And Protection System.

Pre-market Notification Details

Device IDK172132
510k NumberK172132
Device Name:CleanCision Wound Retraction And Protection System
ClassificationWound Retraction And Protection System
Applicant Prescient Surgical, Inc. 1585 Industrial Rd. San Carlos,  CA  94070
ContactLisa Claude
CorrespondentLisa Claude
Prescient Surgical, Inc. 1585 Industrial Rd. San Carlos,  CA  94070
Product CodePQI  
CFR Regulation Number878.4371 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-07-14
Decision Date2017-10-25
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
28685320003014 K172132 000
28685320003007 K172132 000

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