STANDARD SCI-TECH INC.

FDA Device Registration & Listing · Seoul, KR · Registration 3009906660

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3009906660
FEI Number
3009906660
Entity Name
STANDARD SCI-TECH INC.
City/State/Country
Seoul, KR
Establishment Address
1F Sewoon Medical Bldg., 46 Wangsan-Ro, Dongdaemun-Gu, Seoul 02583, KR
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device
Owner / Operator
STANDARD SCI-TECH INC. (Owner Number: 10054336)
Owner / Operator Contact Address
1F Sewoon Medical Bldg., 46 Wangsan-Ro, Dongdaemun-Gu, Seoul, KR-NOTA 02583, KR
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

Bonastent

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FGE Stents, Drains And Dilators For The Biliary Ducts Gastroenterology, Urology Class 2 876.5010 2017-03-08
JCT Prosthesis, Tracheal, Expandable General, Plastic Surgery Class 2 878.3720 2017-03-08
ESW Prosthesis, Esophageal General, Plastic Surgery Class 2 878.3610 2017-03-08

Official Correspondent

DaeHyun Shin

US Agent Details

Brian Lynch Business: Thoracent LLC Email: brian@thoracent.com Phone: (917) 4396742

Related Public Records

Same Entity

STANDARD SCI-TECH INC.
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
K902734 Olympus Corp. PR CANNULAS 1990-08-22

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0008-05 N/A 2
Biliary Stent System (6Fr 9mm x 30mm).
Z-0015-2011 Navilyst Medical, Inc 2
Exodus(TM) 8F (2.7 mm)/25 cm Standard Loop Multipurpose Drainage Catheter with Hydrophilic Coating, REF Catalog No. 10002, UPN Product No. H965100201, Rx ONLY, STERILE/EO --- Made in USA: 2301 Centennial Blvd., Jeffersonville, IN 47130 --- Manufactured for: Navilyst Medical, Inc. 26 Forest Street, Marlborough, MA 01752 USA --- Each box unit contains 5 catheters. --- The Exodus Standard Loop Multipurpose Drainage Catheter consists of a radiopaque polyurethane catheter with a locking pigtail distal end and is coated with a hydrophilic coating. Catheter markings are provided in centimeters on the shaft to indicate the distance form the distal tip. The catheter is provided with a trocar, a metal stiffening cannula and a plastic cannula. Multipurpose Drainage Catheters are intended for percutaneous drainage of fluid in the chest, abdomen and pelvis.
Z-0035-2009 Bard Peripheral Vascular Inc 2
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX060201CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
Z-0036-2009 Bard Peripheral Vascular Inc 2
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX060203CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
Z-0037-2009 Bard Peripheral Vascular Inc 2
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX060301CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009906660. Last updated year: 2026. Please use registration number 3009906660 when referencing this establishment in official correspondence.
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