Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010402713

FEI Number

3010402713

Entity Name

INCYTO CO., LTD.

City/State/Country

Cheonan-si Chungnam, KR

Establishment Address

64, Hongcheondanggok-gil, Ipjang-myeon, Seobuk-gu, Cheonan-si Chungnam 31056, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

INCYTO Co., Ltd. (Owner Number: 10044206)

Owner / Operator Contact Address

64, Hongcheondanggok-gil, Ipjang-myeon, Seobuk-gu, Cheonan-si, KR-44 31056, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

INCYTO Needle

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HMX	Cannula, Ophthalmic	Ophthalmic	Class 1	886.4350	2016-02-17

Official Correspondent

Yanni Yang

US Agent Details

Priscilla Chung Business: LK Consulting Group USA, Inc. Email: juhee.c@lkconsultinggroup.com Phone: (714) 9225276

Related Public Records

Same Entity

INCYTO Co., Ltd.

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K854401	Microsurgical Technology, Inc.	THE NEW MOBILE TIP MCINTYRE CANNULA	1985-12-30

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0011-2019	Ellex iScience, Inc.	1	ellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit, for single use, REF iT-250A, Rx. The firm name on the label is Ellex iScience, Inc., Fremont, CA. Used in ophthalmic surgery.
Z-0022-2009	Becton Dickinson and Company	1	BD Visitec High Viscosity Injector, 4mm Ref: 585173. The product is intended for Vitroretinal Surgery.

Similar Registrations

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3034992373	PLU OPHTHALMIC Corp	Coral Gables, FL, US
3031572059	TissueGUARD	Dresden Saxony, DE
3008754084	Belle Healthcare Technology Co., Ltd.	Suzhou Jiangsu, CN
3008719017	SUMMIT MEDICAL LLC	Saint Paul, MN, US
3012494290	SANICURE BV	SCHIPHOL Noord-Holland, NL

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010402713. Last updated year: 2026. Please use registration number 3010402713 when referencing this establishment in official correspondence.