Cytrellis Dermal Micro-Coring System

Powered Microneedle Device

Cytrellis Biosystems, Inc.

The following data is part of a premarket notification filed by Cytrellis Biosystems, Inc. with the FDA for Cytrellis Dermal Micro-coring System.

Pre-market Notification Details

Device IDK202517
510k NumberK202517
Device Name:Cytrellis Dermal Micro-Coring System
ClassificationPowered Microneedle Device
Applicant Cytrellis Biosystems, Inc. 299C Washington St Woburn,  MA  01801
ContactKaren H. Cronholm
CorrespondentKaren H. Cronholm
Cytrellis Biosystems, Inc. 299C Washington St Woburn,  MA  01801
Product CodeQAI  
CFR Regulation Number878.4430 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-01
Decision Date2021-07-09

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