BIOTEQUE AMERICA, INC.

FDA Device Registration & Listing · Richardson, TX, US · Registration 3024860690

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
3024860690
FEI Number
3024860690
Entity Name
BIOTEQUE AMERICA, INC.
City/State/Country
Richardson, TX, US
Establishment Address
1302 Exchange Drive, Suite # 150, Richardson, TX 75081, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Bioteque America, Inc. (Owner Number: 9053395)
Owner / Operator Contact Address
1302 Exchange Drive., Suite#150, Richardson, TX 75081, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K013289
PMA Number
N/A

All Registered Proprietary Names

Bioteque Curette and Preferred Curette Bioteque HSG and SHG Catheters Bioteque Cervical Dilators Bioteque Uterine Sound Bioteque Vaginal Pessaries

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HHK Curette, Suction, Endometrial (And Accessories) Obstetrics/Gynecology Class 2 884.1175 2007-11-05
LKF Cannula, Manipulator/Injector, Uterine Obstetrics/Gynecology Class 2 884.4530 2007-11-05
HDQ Dilator, Cervical, Fixed Size Obstetrics/Gynecology Class 1 884.4530 2023-01-11
HHM Sound, Uterine Obstetrics/Gynecology Class 1 884.4530 2023-01-11
HHW Pessary, Vaginal Obstetrics/Gynecology Class 2 884.3575 2007-11-05

Official Correspondent

Gary Liu

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Bioteque America, 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
K933654 Johnson & Johnson Medical, Inc. BLADDER NECK SUPPORT PROTHESIS FITTING KIT 1995-05-04

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3024860690. Last updated year: 2026. Please use registration number 3024860690 when referencing this establishment in official correspondence.
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