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510(k) Data Aggregation
K Number
K143447Device Name
Dilapan-S
Manufacturer
Medicem Technology s.r.o.
Date Cleared
2015-04-17
(136 days)
Product Code
PKN
Regulation Number
884.4260Why did this record match?
Applicant Name (Manufacturer) :
Medicem Technology s.r.o.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Dilapan-S is to be used whenever cervical softening and dilation is desired. Some examples are:
- 1. Cervical stenosis
- a. related to dysmenorrhea
- b. considered a possible cause of infertility
- c. resulting from cauterization or conization
- 2. Placement and removal of intrauterine devices
- 3. Induction of labor
- 4. Radium placement
- 5. Drainage of uterine cavity
- 6. Endometrial biopsy
- 7. Uterine curettage
- 8. Suction cannula aspiration
- 9. Operative hysteroscopy
Device Description
DILAPAN-S is a hygroscopic cervical dilator that is manufactured from AQUACRYL, a proprietary hydrogel. The dilators are firm hygroscopic rods, similar in shape to natural laminaria tents. DILAPAN-S is capable of increasing in diameter on average from three (3) millimeters to 8.3-10 mm, or four (4) millimeters to 10-12.5 millimeters within 4-6 hours as they absorb moisture from the genital tract.
In clinical trials, DILAPAN-S has been shown to dilate the cervix gradually. It may not be necessary to use general or local anesthetics during the insertion process, thereby eliminating their associated risks to the patient. A Marker String is tied securely to the handle of the DILAPAN - S, and is provided to indicate location.
DILAPAN-S is capable of increasing its volume as it absorbs moisture from the genital tract through hygroscopic action. The volume of DILAPAN-S subsequently exerts radial pressure on the surrounding structures (uterine neck) to dilate progressively. Endocervical pressure on the uterine neck results in mechanical dilation and promotes cervical ripening through reversible cell dehydration and local endogenous prostaglandins release promoting collagen reorganization.
DILAPAN-S is available in boxes of 10 or 25 dilators and in the following dimensions: 4mm x 65mm, 4mm x 55mm, 3mm x 55mm. Each DILAPAN - S is individually wrapped in a single foil pouch and is sterilized by gamma radiation.
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