PUSEN USA INC

FDA Device Registration & Listing · Johns Creek, GA, US · Registration 3029981244

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
3029981244
FEI Number
3029981244
Entity Name
PUSEN USA INC
City/State/Country
Johns Creek, GA, US
Establishment Address
11340 Lakefield Drive, Suite 200, Johns Creek, GA 30097, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198
Owner / Operator
PUSEN USA Inc (Owner Number: 10089223)
Owner / Operator Contact Address
11340 Lakefield Drive, Suite 200, Johns Creek, GA 30097, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K172098
PMA Number
N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FGB Ureteroscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2023-11-16

Official Correspondent

Keduo Yu

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

PUSEN USA 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
K915458 Psi Medical Products, Inc. URETEROSCOPE 1992-01-30

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3029981244. Last updated year: 2026. Please use registration number 3029981244 when referencing this establishment in official correspondence.
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