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Found 18 results
510(k) Data Aggregation
K Number
K240434Device Name
RELIEEV Suction Curette (Flexible 3.0/ Standard 3.6)
Manufacturer
Li Medical Corporation Ltd.
Date Cleared
2024-09-25
(224 days)
Product Code
HHK
Regulation Number
884.1175Why did this record match?
Product Code :
HHK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The "RELIEEV" Suction Curette (Flexible 3.0/ Standard 3.6) is used to remove samples of materials from the uterus and from the mucosal lining of the uterus by scraping or vacuum suction. These devices obtain tissue samples for purposes of biopsy precancer screening or they can be used for menstrual extraction.
Device Description
The "RELIEEV" Suction Curette is a sterile, disposable, single-use device used to obtain a sample from the uterine mucosal lining. It is available in two models – Flexible 3.0 and Standard 3.6 with outer diameters of 3.0 mm and 3.6 mm respectively. The device consists of a tube and piston made of polypropylene (PP) with a silicone O-ring. The subject device is packaged in medical paper grade pouch (60g).
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K Number
K201952Device Name
CrossGlide ETS Plus
Manufacturer
CrossBay Medical
Date Cleared
2020-08-05
(22 days)
Product Code
HHK
Regulation Number
884.1175Why did this record match?
Product Code :
HHK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CrossGlide™ ETS Plus is indicated for use for sonohysterography and to remove material from the uterus and from the mucosal lining of the uterus by scraping and vacuum suction in order to obtain tissue for histological biopsy.
Device Description
The CrossGlide™ ETS Plus is a sterile, disposable, single-use device which enables saline infusion sonohysteroraphy and the removal of mucosal tissue from the uterus for histological biopsy. The CrossGlide™ ETS Plus contains a Delivery Catheter with an everting Membrane, an Inner Aspiration Catheter that contains a lumen for saline infusion and aspiration. The everting Membrane places the Inner Aspiration Catheter into the uterine cavity. A proximal luer connector allows a 10cc luer lock syringe to infuse saline into the uterine cavity for sonohysterography. The 10cc syringe can be used to remove the saline from the uterine cavity and create negative pressure. Movement of the CrossGlide™ ETS Plus device, after creating negative pressure with the 10cc syringe, removes material and tissue from the uterine cavity.
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K Number
K192534Device Name
CrossBay Endometrial Tissue Sampler (ETS)
Manufacturer
CrossBay Medical
Date Cleared
2020-03-25
(191 days)
Product Code
HHK
Regulation Number
884.1175Why did this record match?
Product Code :
HHK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CrossGlideTM ETS, Endometrial Tissue Sampler, is indicated for use to remove material from the uterus and from the mucosal lining of the uterus by scraping and vacuum suction in order to obtain tissue for histological biopsy.
Device Description
The CrossGlide™ ETS, Endometrial Tissue Sampler, is a sterile, disposable, single-use device which enables the removal of mucosal tissue from the uterus for histological biopsy. The CrossGlide™ ETS contains a Delivery Catheter with an everting Membrane and an Inner Aspiration Catheter. The everting Membrane places the Inner Aspiration Catheter into the uterine cavity. Movement of the ETS device, after creating negative pressure with the 3cc syringe, removes material and tissue from the uterine cavity.
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K Number
K102847Device Name
DISPOSABLE ENDOMETRIAL SUCTION CURETTE
Manufacturer
JIANGSU SUYUN MEDICAL MATERIALS CO., LTD.
Date Cleared
2011-04-14
(197 days)
Product Code
HHK
Regulation Number
884.1175Why did this record match?
Product Code :
HHK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Disposable Endometrial Suction Curette is indicated for obtaining endometrial tissue samples by vacuum suction for endometrial histopathology examination. The specimens obtained are then used for the following: Endometrial cancer detection, Determine response to estrogen replacement therapy, Detection of pathology resulting in: Infertility, menstrual disorders, abnormal or dysfunctional uterine bleeding, postmenopausal bleeding, endometrial dating.
Device Description
The proposed device is single-use, sterile disposable endometrial suction curette, which is intended to obtain endometrial tissue samples by vacuum suction mainly for endometrial histopathology examination and cytological examination or clinical examination in Gynaecological examination. Disposable Endometrial Suction Curette, including Type A and Type B, consists of a rod, barrel ' and sealing ring. The rod is used to generate negative pressure to draw the sample (fluid or mucous) into the barrel. The barrel is used to contain the drawn samples. The sealing ring ensures that the handle can be assembled closed with the barrel for keeping certain negative pressure.
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K Number
K092982Device Name
THE PANPAC SUCTION CURETTE
Manufacturer
Panpac Medical Corporation
Date Cleared
2010-07-26
(301 days)
Product Code
HHK
Regulation Number
884.1175Why did this record match?
Product Code :
HHK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
An endometrial suction curette, such as The Curette and Preferred Curette (available in 2.5 and 3.0 mm outer diameters), are devices used to remove samples of materials from the uteris and from the mucosal lining of the uterus by scraping or vacuum suction. These devices obtain itssue samples for purposes of biopsy precancer screening or they can be used for menstrual extraction.
Device Description
An endometrial suction curette, such as The Curette and Preferred Curette (available in 2.5 and 3.0 mm outer diameters), are devices used to remove samples of materials from the uteris and from the mucosal lining of the uterus by scraping or vacuum suction.
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K Number
K051294Device Name
FEMTEST ENDOMETRIAL SUCTION CURETTE, MODEL FT-1
Manufacturer
FEMSPEC L.L.C.
Date Cleared
2005-12-21
(217 days)
Product Code
HHK
Regulation Number
884.1175Why did this record match?
Product Code :
HHK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
FemSpec, LLC, FemTest™ Endometrial Suction Curette is a sterile, disposable curette indicated for single patient use in obtaining tissue samples from the endocervical canal and for histological analysis of the uterine mucosal lining. It is indicated for:
- Cancer screening
- Endometrial dating
- Determining response to estrogen replacement therapy
- Bacterial culturing
- Detection of pathology resulting in infertility
- Monitoring patients receiving Tamoxifen therapy
- Evaluating secondary amenorrhea
Device Description
FemSpec, LLC, FemTest™ Endometrial Suction Curette is a sterile, disposable curette.
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K Number
K040189Device Name
ENDOMETRIAL SAMPLING SYRINGE
Manufacturer
ROCKET MEDICAL PLC
Date Cleared
2004-10-04
(250 days)
Product Code
HHK
Regulation Number
884.1175Why did this record match?
Product Code :
HHK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Endometrial Sampling Syringe can be used for a variety of clinical conditions which could include the following:
- For histological biopsy of the endometrium & endo-cervix in post menopausal screening. .
- Hormone therapy monitoring. .
- Endometrial dating .
- Detection of endometrial carcinoma .
- Bacterial culturing .
Device Description
This device is being designed to allow the safe and effective the histologic biopsy of the endomethum "and" endometrial carcinoma, endometrial dating and bacterial culturing. This is achieved by a design where the slim form of the sampling syringe makes in most This is actieved by a dealer which as a polypropylene sheath permitting easy entry into the uterine cavity. The sheath / cannula mechanism gives good suction and when combined with the shape and form of the curette opening gives good sample extraction.
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K Number
K021876Device Name
MAS WITH OR WITHOUT SYRINGE
Manufacturer
MARINA MEDICAL INSTRUMENTS, INC.
Date Cleared
2003-04-08
(305 days)
Product Code
HHK
Regulation Number
884.1175Why did this record match?
Product Code :
HHK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
THE DEVICE IS INDICATED FR USE To Rt MATERIAL THE UTERUS 1010 UTERUS By SCRAPING / / N THE AND SUCTION IN ORDER TO OBTAIN નિર રે. 151-624 LOGICAL MENSTRALAL of for EXTRACTIO
Device Description
The ETO sterilized MAS w/ Syringe is used to obtain a sample of differential endometrial tissue. The MAS w/ syringe is a 3mm (O.D.) endometrial suction device that has a Randall-like cutting edge at its distal end and is packaged with a twist-and-lock syringe. The syringe will provide a vacuum or suction during the procedure. The MAS w/ syringe is sterile unless the package is opened or damaged and designed for single patient use only.
The ETO sterilized MAS without syringe is used to obtain a sample of differential endometrial tissue. The MAS is a m 3.5mm (O.D.) endometrial suction curette that has a fenestration on the wall at its distal end and a tight fitting piston that will provide a vacuum or suction during the procedure as it is pulled proximally. The MAS is sterile unless the package is opened or damaged and designed for single patient use only.
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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?
Product Code :
HHK
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
K001555Device Name
SURESAMPLE-WALLACE ENDOMETRIAL SAMPLER, ENDO 26
Manufacturer
SIMS PORTEX LTD.
Date Cleared
2000-08-02
(76 days)
Product Code
HHK
Regulation Number
884.1175Why did this record match?
Product Code :
HHK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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