Ultratellege USA Co. LTD.

FDA Device Registration & Listing · Erie, PA, US · Registration 3009543101

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
3009543101
FEI Number
3009543101
Entity Name
Ultratellege USA Co. LTD.
City/State/Country
Erie, PA, US
Establishment Address
2111 Peninsula Drive, Erie, PA 16506, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Ultratellege USA Co. Ltd (Owner Number: 10040377)
Owner / Operator Contact Address
2111 Peninsula Drive, Erie, PA 16506, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K162119
PMA Number
N/A

All Registered Proprietary Names

UreTron Multi Probe Lithotripter System UreTron Flexible Probe

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FFK Lithotriptor, Electro-Hydraulic Gastroenterology, Urology Class 2 876.4480 2016-08-01
FFK Lithotriptor, Electro-Hydraulic Gastroenterology, Urology Class 2 876.4480 2016-08-30

Official Correspondent

Tao Song

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Ultratellege USA 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
K885255 Candela Laser Corp. MDL-1 LASERTRIPTER(TM) 1989-06-01

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009543101. Last updated year: 2026. Please use registration number 3009543101 when referencing this establishment in official correspondence.
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