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510(k) Data Aggregation
K Number
K021012Device Name
LAMINARIA 2MM/3MM/4MM/5MM/6MM/7MM/8MM/9MM
Manufacturer
QUALITY MEDICAL SOLUSIONS LLC
Date Cleared
2002-06-25
(88 days)
Product Code
HDY
Regulation Number
884.4260Why did this record match?
Applicant Name (Manufacturer) :
QUALITY MEDICAL SOLUSIONS LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Laminaria is intended for use whenever it is desirable to dilate the cervical canal, such as Uterine curettage, Labor induction, IUD placement and removal, and Radium placement
Device Description
This single use device is a hygroscopic laminaria cervical dilator designed to dilate (stretch open) the cervical os by cervical insertion of a cylindrical and expansible material into the cervical canal, made from the root of a seaweed (laminaria digitata). Laminaria expands when it absorbs moisture.
The ability to increase in size slowly (usually 6 to 24 hours) is of advantage in physiologically dilating a closed body orifice such as the cervical canal. When used improperly, it may cause the patient major discomfort or uterine complications
Laminaria is available in 2, 3, 4, 5, 6, 7, 8 and 9 mm diameter sizes with a length varving between 50 and 65 mm. Each laminaria is drilled and attached to a 75-95 mm string to facilitate removal from the cervical canal (the last digit of the product code reflects its size)
Laminaria is intended for use whenever it is desirable to dilate the cervical canal, such as uterine or suction curettage, labor induction, IUD placement and removal, and Radium placement
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