Product Classification

• Device: speculum, vaginal, nonmetal, fiberoptic
• Regulation Description: Obstetric-gynecologic specialized manual instrument.
• Regulation Medical Specialty: Obstetrics/Gynecology
• Review Panel: Obstetrics/Gynecology
• Product Code: HIC
• Submission Type: 510(k)
• Regulation Number: 884.4530
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Third Party Review

• Eligible for Accredited Persons Expansion Pilot Program

Accredited Persons

• dekra certification b.v.
• intertek testing services
• regulatory technology services, llc
• tuv sud america inc.
• underwriters laboratories, inc.