Product Classification

• Device: catheter, balloon, dilation of cervical canal prior to labor
• Regulation Description: Hygroscopic Laminaria cervical dilator.
• Definition: Mechanical dilation of the cervical canal for labor.
• Physical State: Catheter with inflatable balloon
• Technical Method: Use mechanical force to dilate cervix to prepare for vaginal delivery.
• Target Area: Uterine cervix
• Regulation Medical Specialty: Obstetrics/Gynecology
• Review Panel: Obstetrics/Gynecology
• Product Code: PFJ
• Premarket Review: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices (OHT3); 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