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510(k) Data Aggregation
K Number
K182049Device Name
exCellerator Cervical Collection Device
Manufacturer
ExCell Company LLC
Date Cleared
2019-04-25
(268 days)
Product Code
HHT
Regulation Number
884.4530Why did this record match?
Product Code :
HHT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ExCellerator Cervical Collection Device is a cervical spatula intended for collecting ectocervical specimens for the ThinPrep Pap test. The device is also intended to be used to aid in a more complete transfer of the specimen material from the endocervical brush (cytobrush) to the PreservCyt solution for ThinPrep testing. The ExCellerator device must be used with an IVD labeled endocervical brush.
Device Description
The ExCellerator™ Cervical Collection Device is a non-sterile, single use, disposable cervical sampling device (spatula), comprised of inert food grade polypropylene plastic, intended for sampling the ectocervix during the cervical sample collection procedure. Additionally, it aids in more complete transfer of the cytological sample collected with an IVD labeled endocervical brush (cytobrush) into the PreservCyt vial for the preparation of ThinPrep Pap test slides.
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K Number
K153128Device Name
Kolplast Cervical Sample Collection Kit
Manufacturer
KOLPLAST CI SA
Date Cleared
2017-01-13
(442 days)
Product Code
HHT
Regulation Number
884.4530Why did this record match?
Product Code :
HHT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Kolplast Cervical Sample Collection Kit is intended for collection of cytological specimens from the ectocervix and the endocervix for conventional Pap Smear Test or Liquid-Based ThinPrep® Pap Test with PreservCyt® solution.
For prescription use only.
It is not intended for use in pregnant women and should be used by a clinical or other qualified health professional only.
Device Description
The Kolplast Cervical Sample Collection Kit is composed of the Kolplast Cervical Brush Protected Tip and the Kolplast Cervical Plastic Spatula and is a single use, non-sterile, disposable manual gynecological device. The Cervical Brush Protected Tip is intended for the collection of cytological specimens from the endocervix and the Cervical Plastic Spatula is intended for the collection of cytological specimens from the ectocervix. The Cervical Brush Protected Tip has a head consisting of white nylon bristles, and secured by stainless steel to the plastic handle. During collection of endocervical cells, the Cervical Brush Protected Tip is inserted into the cervix, rotated once via the handle and removed from the cervix. The collected cytological specimen is then transferred to the glass slide by smearing, or to the preservative fluid in a container by rotating the tip 10 times while pushing against the container wall. The Kolplast Plastic Spatula is made of plastic and incorporates a long edge and a notched end. During collection of ectocervical cells, the notched end is put against and rotated 360° around the circumference of the ectocervix. The retained cytological specimen is then transferred to the same glass slide by smearing, or to the preservative fluid in the same container by swirling 10 times. The collected samples on glass slide, or in preservative fluid in a container will be sent to a cytology lab for Pap Test analysis.
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K Number
K141057Device Name
DISPOSABLE CERVICAL BRUSH
Manufacturer
NINGBO HLS MEDICAL PRODUCTS CO., LTD
Date Cleared
2015-05-14
(385 days)
Product Code
HHT
Regulation Number
884.4530Why did this record match?
Product Code :
HHT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Disposable Cervical Brush is intended for the collection of cervical cells for analysis by Pap smear methods. It is not intended for use in pregnant women and should be used by a clinician or other qualified health professional only.
Device Description
The Disposable Cervical Brush is a non-sterile, disposable, colored cytological cervical spatula intended for collecting cytological materials from the surface of the cervix. This device consists of two components: a white colored head and a pink colored handle. The head contains a brush and a connection portion. The head and handle are physically connected through a male/female connection mechanism. The handle is made of Polypropylene (PP) and the head is made of low density polyethylene (LDPE). This device has a 3-years shelf-life.
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K Number
K111681Device Name
HISTOBRUSH
Manufacturer
PURITAN MEDICAL PRODUCTS COMPANY LLC
Date Cleared
2012-01-19
(218 days)
Product Code
HHT
Regulation Number
884.4530Why did this record match?
Product Code :
HHT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To obtain endocervical cells for Pap smear cytology test
Device Description
The Puritan Histobrush consists of nylon bristles secured by stainless steel to a plastic handle. The device is used to obtain endocervical samples for Pap smear cytology. The device is for single use only and is non-sterile.
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K Number
K083012Device Name
PAPCONE
Manufacturer
OTTO BOCK PUR LIFE SCIENCE GMBH
Date Cleared
2009-04-09
(182 days)
Product Code
HHT
Regulation Number
884.4530Why did this record match?
Product Code :
HHT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
PapCone® is a medical device intended for the collection of exfoliated cervical cells for analysis by Pap smear methods. The PapCone is not intended for use in pregnant women.
Device Description
The PapCone® consists of an axially symmetric polystyrene grip with a round platform carrying a foam cone (PUR Foam B 2240), which is intended to collect exfoliated epithelial cervical cells for andysis by Pap smear methods. Due to its shape, dimension and the porosity of the foam used for PapCone® it is possible to obtain cells from the endocervix and the ectocervix. The design of the foam prevents distortion of the cells during sampling and transfer. During a gynecological examination the foam cone portion of the PapCone® is inserted for $1/3 into the cervical canal and is rotated two times for collection of cervical cells are transferred to a glass slide by applying gentle pressure and rotating the PapCone® evenly against the direction of streak on the slide, this allows for a uniform distribution of cells on the slide. To ensure the adequate coverage of the periphery of the transition zone, it is generally recommended to swap the periphery additionally with a second instrument (e.g. PapCone® or a spatula). Transfer these cells to the same glass slide. The device is offered non sterile.
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K Number
K081522Device Name
BIO NUCLEAR DIAGNOSTICS (ENDO)CERVICAL SAMPLER FOR GYN CYTOLOGY
Manufacturer
BIO NUCLEAR DIAGNOSTICS, INC.
Date Cleared
2008-12-05
(189 days)
Product Code
HHT
Regulation Number
884.4530Why did this record match?
Product Code :
HHT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The (Endo)cervical Sampler is intended for the collection of endocervical cells for PAP smear analysis. This device is not intended for use in pregnant women.
Device Description
Not Found
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K Number
K072381Device Name
SOFTPAP CERVICAL CELL COLLECTOR
Manufacturer
CYTOCORE, INC.
Date Cleared
2008-01-30
(159 days)
Product Code
HHT, SOF
Regulation Number
884.4530Why did this record match?
Product Code :
HHT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For the collection of cervical cytology specimens for Pap test analysis. The SoftPAP™ Cervical Sample Collector should not be used after the first 10 weeks of gestation in pregnant patients.
Device Description
The CytoCore, Inc. SoftPAP™ Collector is a multicomponent assembly for the collection of exfoliated cervical epithelial cells. Its major components are a disposable Balloon assembly (Balloon and rod), and a reusable Handle. The Balloon provides the conformal surface upon which the cells are collected. The Handle provides a means of manipulating and expanding the Balloon during the sampling process. The Balloon inflates against the cervix and conformally contacts the entire areas to be sampled, namely the ectocervical, the transformation zone, and the endocervical surfaces.
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K Number
K062433Device Name
DIAMICS CERCOL CERVICAL SAMPLE COLLECTOR SYSTEM
Manufacturer
DIAMICS, INC.
Date Cleared
2007-03-16
(207 days)
Product Code
HHT
Regulation Number
884.4530Why did this record match?
Product Code :
HHT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Diamics CerCol Cervical Sample Collector is indicated for the collection of cervical cytology material and its transfer for Pap analysis. The Diamics CerCol Cervical Sample Collector is not intended for use in pregnant women.
Device Description
This device consists of a reusable handle and a multi-component assembly. The reusable handle provides a means of expanding and manipulating the CerCol™ Cervical Sample Collector so that the surface areas of the endo-cervix, ecto-cervix and transition zones of the cervix are completely contacted by the CerCol™ Cervical Sample Collector tip for the collection, transport, analysis and testing of exfoliated cervical epithelial cells. The CerCol™ Cervical Sample Collector will be available as a single use, non-sterile disposable device and the reusable handle will be available separately, but both components must be used together as part of the CerCol™ Cervical Sample Collector System.
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K Number
K043369Device Name
CERVEX-BRUSH COMBI
Manufacturer
ROVERS MEDICAL DEVICES B.V.
Date Cleared
2005-02-02
(56 days)
Product Code
HHT
Regulation Number
884.4530Why did this record match?
Product Code :
HHT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Cervex-Brush Combi is intended for the collection of cervical cells for analysis by Pap smear methods and / or by methods for detecting sexually transmitted disease (STD). The Cervex-Brush Combi is not intended for use in pregnant women.
Device Description
This device consists of handle with a multi-bristled, soft plastic brush mounted on it. The bristles are intended to collect cervical cells for testing and evaluation. For the middle part of the Cervex-Brush Combi the cell-collecting ability of the device is comprised of substantially eccentrically placed parallel plastic bristles, forming a brush head that is connected to the handle. The eccentrically placed bristles are positioned on opposite sides of a square base. The top of the brush is rounded. Digital rotation with gentle pressure by way of the handle causes to scrape and remove cytological material simultaneously from the ectocervix and the endocervix. Because the bristles are plastic, wet or humid cells are not absorbed so that the cytological material can easily be transferred to a glass slide or a preservative fluid and sent to the laboratory for evaluation. The device is offered sterile and nonsterile. The Cervex-Brush Combi head is composed of polyethylene, the same material that is used for the Cervex- Brush.
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K Number
K042527Device Name
SPATULA, CERVICAL, CYTOLOGICAL, MODEL 22-9107
Manufacturer
MEDICAL ACTION INDUSTRIES, INC.
Date Cleared
2004-11-08
(52 days)
Product Code
HHT
Regulation Number
884.4530Why did this record match?
Product Code :
HHT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For use as a diagnostic accessory. A blunt instrument used to scrape and remove cytological material from the surface of the cervix or vagina.
Device Description
Cervical Scraper
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