Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3020704367

FEI Number

3020704367

Entity Name

CYTRELLIS BIOSYSTEMS, INC.

City/State/Country

Woburn, MA, US

Establishment Address

34 Commerce Way, Woburn, MA 01801, US

Establishment Type(s)

Repack or Relabel Medical Device,Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Cytrellis Biosystems, Inc. (Owner Number: 10082569)

Owner / Operator Contact Address

34 Commerce Way, Woburn, MA 01801, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K202517

PMA Number

N/A

All Registered Proprietary Names

Ellacor(R) System with Micro-Coring(TM) Technology

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QAI	Powered Microneedle Device	General, Plastic Surgery	Class 2	878.4430	2021-08-16

Official Correspondent

Robert Hinz

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Cytrellis Biosystems, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3020704367. Last updated year: 2026. Please use registration number 3020704367 when referencing this establishment in official correspondence.