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U.S. Department of Health and Human Services

Product Classification

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Device catheter, balloon, dilation of cervical canal
Regulation Description Hygroscopic Laminaria cervical dilator.
Definition Mechanical dilation and softening of the cervix.
Physical State Catheter with inflatable balloons.
Technical Method When placed in the cervical canal, the device uses mechanical force to dilate and soften the cervix.
Target Area Cervical canal
Regulation Medical Specialty Obstetrics/Gynecology
Review Panel Obstetrics/Gynecology
Product CodePON
Premarket Review Office of Device Evaluation (ODE)
Division of Reproductive, Gastro-Renal, and Urological Devices (DRGUD)
Obstetrics and Gynecology Devices Branch (OGDB)
Submission Type 510(k)
Regulation Number 884.4260
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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