Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014664527

FEI Number

3014664527

Entity Name

BISTOOL INC

City/State/Country

Seoul, KR

Establishment Address

1, 3, 5 F, Deokseong-bldg., 9, Gwangnaru-ro 6-gil, Seongdong-gu, Seoul 04796, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Bistool Inc (Owner Number: 10058048)

Owner / Operator Contact Address

1, 3, 5 F, Deokseong-bldg., 9, Gwangnaru-ro 6-gil, Seongdong-gu, Seoul, KR-NOTA 04796, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K171851

PMA Number

N/A

All Registered Proprietary Names

SOFTXiL

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MIB	Elastomer, Silicone Block	Ear, Nose, Throat	Class 2	874.3620	2018-06-29

Official Correspondent

Eunhyun Bae

US Agent Details

chuljoo jeon Business: KTR Americas Inc. Email: americas@ktr.or.kr Phone: (562) 3172865

Related Public Records

Same Entity

Bistool 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 3014664527. Last updated year: 2026. Please use registration number 3014664527 when referencing this establishment in official correspondence.