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510(k) Data Aggregation
K Number
K103695Device Name
PREPEX SYSTEM
Manufacturer
CIRC MEDTECH
Date Cleared
2012-01-10
(389 days)
Product Code
HFX
Regulation Number
884.4530Why did this record match?
Applicant Name (Manufacturer) :
CIRC MEDTECH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
PrePex is indicated for circumcision of adult males. Prepex is intended to be placed and removed by a health care professional trained in male circumcision and in use of the PrePex device.
Device Description
The PrePex is a device composed of three components; a plastic Inner Ring, an Elastic outer clamping Ring and a Placement Ring for applying the clamping Elastic Ring. The PrePex System is sold sterile for single use and is available in multiple sizes to accommodate variances in adult patients. A sizing guide is separately available, sold clean for single use
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