Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3018490308

FEI Number

3018490308

Entity Name

KITE ENDOSCOPIC INNOVATIONS LLC

City/State/Country

Concord Township, OH, US

Establishment Address

10443 Johnnycake Ridge Rd, Concord Township, OH 44077, US

Establishment Type(s)

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

Owner / Operator

Kite Endoscopic Innovations LLC (Owner Number: 10081117)

Owner / Operator Contact Address

10443 Johnnycake Ridge Rd, Concord Township, OH 44077, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Core Catcher Clam Shell, AFFIX AFFIX

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IDX	Sieves, Tissue	Pathology	Class 1	864.3010	2021-03-18
MJI	Specimen/Tissue, Identification Orientation	Pathology	Class 1	864.3010	2021-03-18
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2021-03-18

Official Correspondent

Dean Secrest

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Kite Endoscopic Innovations LLC

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 3018490308. Last updated year: 2026. Please use registration number 3018490308 when referencing this establishment in official correspondence.