Product Classification

• 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 Code: PON
• 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 Reporting: Ineligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• global quality and regulatory services
• regulatory technology services, llc
• third party review group, llc