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Found 4 results
510(k) Data Aggregation
K Number
K041094Device Name
HSG CATHETER SET
Manufacturer
BIOTEQUE AMERICA, INC.
Date Cleared
2004-06-17
(51 days)
Product Code
LKF
Regulation Number
884.4530Why did this record match?
Applicant Name (Manufacturer) :
BIOTEQUE AMERICA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Bioteque's HSG catheter sets are indicated to evaluate the causes of abnormal uterine bleeding, menstrual disorders, recurring pregnancy loss, or unexplained infertility. They can also be used to assess uterine pathology and patients on tamoxifan therapy.
HSG type catheter sets are used to infuse a fluid (either a contrast media or a sterile saline) into the uterine cavity while blocking the external cervical OS to retain the fluid in the uterus during the procedure.
Device Description
Not Found
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K Number
K020628Device Name
CURELLE, PREFERRED CURELLE, CUTEQ 2.5
Manufacturer
BIOTEQUE AMERICA, INC.
Date Cleared
2002-05-24
(87 days)
Product Code
HHK
Regulation Number
884.1175Why did this record match?
Applicant Name (Manufacturer) :
BIOTEQUE AMERICA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
An endometrial suction curette, such as Bioteque's Curelle, Preferved Corelle, or Coteq 2.5, are devices used to remove samples of materials from the uterus and from the mucosal lining of thee uterus by scraping or vacuum suction These devices obtain tissue samples for purpos of biopsy & precancer screening or they can be used for menstrual extraction.
Device Description
An endometrial suction curette, such as Bioteque's Curelle, Preferved Corelle, or Coteq 2.5
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K Number
K013289Device Name
BIOTEQUE VAGINAL PESSARIES
Manufacturer
BIOTEQUE AMERICA, INC.
Date Cleared
2001-12-27
(86 days)
Product Code
HHW
Regulation Number
884.3575Why did this record match?
Applicant Name (Manufacturer) :
BIOTEQUE AMERICA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Bioteque's vaginal pessaries are indicated as removable devices placed in the vaginal cavity to provide a non-surgical alternative for the treatment of organ prolapse and to relieve the symptoms of pelvic relaxation with and without urinary incontinence.
Device Description
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K Number
K003380Device Name
BIOTEQUE VAGINAL DILATOR
Manufacturer
BIOTEQUE AMERICA, INC.
Date Cleared
2001-01-29
(90 days)
Product Code
HDX
Regulation Number
884.3900Why did this record match?
Applicant Name (Manufacturer) :
BIOTEQUE AMERICA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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