Product Classification

• 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 Code: PKN
• 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: Eligible
• 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