Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004434200

FEI Number

3004434200

Entity Name

LG Electronics Nanjing New Technology Co., Ltd.

City/State/Country

Nanjing Jiangsu, CN

Establishment Address

NO.346, Yaoxin Road, Economic & Technical Development Zone, Nanjing Jiangsu 210038, CN

Establishment Type(s)

Manufacture Medical Device,Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

LG Electronics Inc Monitor Division. (Owner Number: 10053135)

Owner / Operator Contact Address

222, LG-ro, Jinwi-myeon, Pyeongtaek-si, KR-41 17709, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K241402

PMA Number

N/A

All Registered Proprietary Names

27HS714S 21HQ613D 21HQ513D 31HN713D 32HL512D 32HQ713D 21HK512D 24HR513C 27HJ713S 32HS710S 32HQ713D 32HL512D 31HN713D 21HQ513D 32HQ713D 31HN713D 32HL512D 21HQ513D 32HR734S

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2025-02-10
PGY	Display, Diagnostic Radiology	Radiology	Class 2	892.2050	2024-02-20
PGY	Display, Diagnostic Radiology	Radiology	Class 2	892.2050	2024-06-19
PGY	Display, Diagnostic Radiology	Radiology	Class 2	892.2050	2019-12-05
PGY	Display, Diagnostic Radiology	Radiology	Class 2	892.2050	2024-01-03
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2017-06-13
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2025-07-23
PGY	Display, Diagnostic Radiology	Radiology	Class 2	892.2050	2024-06-19
PGY	Display, Diagnostic Radiology	Radiology	Class 2	892.2050	2022-01-06
PGY	Display, Diagnostic Radiology	Radiology	Class 2	892.2050	2023-03-08
PGY	Display, Diagnostic Radiology	Radiology	Class 2	892.2050	2020-10-14
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2020-03-16
PGY	Display, Diagnostic Radiology	Radiology	Class 2	892.2050	2020-03-16
PGY	Display, Diagnostic Radiology	Radiology	Class 2	892.2050	2024-06-19
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2024-08-27

Official Correspondent

Jin-Hwan Jun

US Agent Details

Heejae Cho Email: heejae.cho@lge.com Phone: (201) 4722623

Related Public Records

Same Entity

LG Electronics Inc Monitor Division.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3013501671	LG ELECTRONICS INC.	Gumi-si Gyeongbuk, KR

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K914997	Conmedcorp	ASP-IRRATOR	1992-01-07
K153773	Olympus Medical Systems Corp.	Disposal Lens Cleaning Sheath	2016-11-22
K940141	Micro-Medical Devices, Inc.	LAPARAOSCOPES ELECTRONIC WITH STERILE SHEATH	1994-05-19
K933812	Advanced Surgical, Inc.	ADVANCED SURGICAL, INC. CANNULA CLEANING DEVICE AND ACCESSORIES	1993-12-13
K254228	Karl Storz SE & CO. KG	KARL STORZ Trocars with Valve Seals	2026-05-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0398 Contains: (2) C0Q04, 5x100mm Threaded Kii Access System (1) C0604, 15x100mm Non-Threaded Separator System w/Universal Seal, for laparoscopic procedures.
Z-0028-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0406 Contains: (1) C0658, 11x100mm Threaded Shielded Trocar w/Universal Seal (1) C0522, 5x100mm Threaded Premium Flat Blade (1) C2202, 150mm Insufflation needle (1) C0605, 15x100mm Threaded Separator Access System (1) CB030, 5mm x 35cm Direct Drive Disposable Scissors (2) C4120, 5mm x 38cm Direct Drive Grasper Reposable Cartridge, for laparoscopic procedures.
Z-0029-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Roux-EN-Y Kit, REF: K2129 Contains: (1) C0Q04, 5x100mm Threaded Kii Access System (1) C0130, 12x100mm Optical Separator System, Non-handled (2) C0Q10, 5x100mm Threaded Kii Cannula and Seal (1) C0605, 15mmx100mm Threaded Cannula System, for laparoscopic procedures.
Z-0012-2022	GE Healthcare, LLC	2	Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
Z-0023-2016	GE Healthcare	2	Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004434200. Last updated year: 2026. Please use registration number 3004434200 when referencing this establishment in official correspondence.