Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013023209

FEI Number

3013023209

Entity Name

INSUNG MEDICAL CO., LTD.

City/State/Country

WONJU-SI Gangwon, KR

Establishment Address

168, GIEOPDOSI-RO, JIJEONG-MYEON, WONJU-SI Gangwon 26354, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

INSUNG MEDICAL CO., LTD. (Owner Number: 10078318)

Owner / Operator Contact Address

168, GIEOPDOSI-RO, JIJEONG-MYEON, WONJU-SI, KR-42 26354, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ANKOR endobronchial tube (Models: ABC33L, ABC35L, ABC37L, ABC39L, ABC33R, ABC35R, ABC37R, ABC39R) ANKOR endobronchial tube (Models: HBC33L, HBC35L, HBC37L, HBC39L, HBC33R, HBC35R, HBC37R, HBC39R) Human-broncho endobronchial tube (Models: HBC33L, HBC35L, HBC37L, HBC39L, HBC33R, HBC35R, HBC37R, HBC39R) Suction Catheter (Models: Y-110, Y-112)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CBI	Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)	Anesthesiology	Class 2	868.5740	2021-05-13
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	Class 1	868.6810	2020-10-19

Official Correspondent

Song Inkeum

US Agent Details

Jung Ryun Ahn Business: KMC USA, Inc Email: kmc.usa@kmcerti.com Phone: (646) 3576058

Related Public Records

Same Entity

INSUNG MEDICAL 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
K071694	Daiken Medical Co, Ltd.	COOPDECH ENDOBRONCHIAL BLOCKER TUBE, MODELS BBT-A30XXX, BBT-B30XXX	2008-03-20

Similar Registrations

Registration Number	Establishment Name	Location
1820334	Cook Incorporated	Bloomington, IN, US
3006984712	HENAN TUOREN MEDICAL DEVICE CO., LTD.	Changyuan Henan, CN
3012307300	ICU Medical, Inc.	Minneapolis, MN, US
3007134520	TELEFLEX MEDICAL	ATHLONE Westmeath, IE
3004748541	Salter Labs	El Paso, TX, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013023209. Last updated year: 2026. Please use registration number 3013023209 when referencing this establishment in official correspondence.