Data / Medical devices / United States / Bioteque America, Inc.
Bioteque America, Inc.: FDA-registered device maker in Richardson, TX, United States, 4 510(k) clearances
Bioteque America, Inc. is registered with the FDA (registration 3024860690) in Richardson, TX, United States. It lists 6 device types. The FDA files 4 510(k) clearances under its listings, the newest dated June 17, 2004. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3024860690
- Address
- 1302 Exchange Drive, Suite # 150, Richardson, TX, United States, 75081
- Owner or operator
- Bioteque America, Inc. (9053395)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler
- First device listed
- November 5, 2007
- Registered through
- 2027
- Brand names listed
- Bioteque Cervical Dilators, Bioteque Curette and Preferred Curette, Bioteque HSG and SHG Catheters, Bioteque Uterine Sound, Bioteque Vaginal Dilators, Bioteque Vaginal Pessaries
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cannula, Manipulator/Injector, Uterine | LKF | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Curette, Suction, Endometrial (And Accessories) | HHK | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Dilator, Cervical, Fixed Size | HDQ | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Dilator, Vaginal | HDX | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Pessary, Vaginal | HHW | 2 | Manufacturer | accessdata.fda.gov |
| Sound, Uterine | HHM | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 17, 2004 | K041094 | HSG CATHETER SET | LKF | Substantially Equivalent | Bioteque America, Inc. | accessdata.fda.gov |
| May 24, 2002 | K020628 | CURELLE, PREFERRED CURELLE, CUTEQ 2.5 | HHK | Substantially Equivalent | Bioteque America, Inc. | accessdata.fda.gov |
| December 27, 2001 | K013289 | BIOTEQUE VAGINAL PESSARIES | HHW | Substantially Equivalent | Bioteque America, Inc. | accessdata.fda.gov |
| January 29, 2001 | K003380 | BIOTEQUE VAGINAL DILATOR | HDX | Substantially Equivalent | Bioteque America, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Dilator, Vaginal
- All makers of Cannula, Manipulator/Injector, Uterine
- All makers of Curette, Suction, Endometrial (And Accessories)
- All makers of Dilator, Cervical, Fixed Size
- All makers of Pessary, Vaginal
- All makers of Sound, Uterine
Updated June 17, 2004. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.