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510(k) Data Aggregation
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?
Applicant Name (Manufacturer) :
OTTO BOCK PUR LIFE SCIENCE GMBH
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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