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U.S. Department of Health and Human Services

Product Classification

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Device dilator, cervical, synthetic, osmotic
Regulation Description Hygroscopic Laminaria cervical dilator.
Definition Cervical softening and dilation
Physical State Small mass of synthetic material
Technical Method When placed in the cervical canal, the device absorbs moisture, swells, and exerts radial pressure on the surrounding structures, resulting in mechanical dilation and promotion of cervical ripening.
Target Area Cervical canal
Regulation Medical Specialty Obstetrics/Gynecology
Review Panel Obstetrics/Gynecology
Product CodePKN
Premarket Review Reproductive, Gynecology and Urology Devices (DHT3B)
Reproductive, Gynecology and Urology Devices (DHT3B)
Submission Type 510(k)
Regulation Number 884.4260
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons