• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Product Classification

  • Print
  • Share
  • E-mail
New Search Back to Search Results
Device sampler, endocervical
Regulation Description Endocervical aspirator.
Definition Obtains tissue samples from the endocervical canal for histological analysis.
Physical State handle and sheath with collection tip; collection tip is designed to scrape endocervical canal and collect an endocervical tissue sample
Technical Method inserted manually through the vaginal and into the endocervix; collection tip scrapes the endocervical canal and collects endocervical tissue sample
Target Area cervix
Regulation Medical Specialty Obstetrics/Gynecology
Review Panel Obstetrics/Gynecology
Product CodePCF
Premarket Review Reproductive, Gynecology and Urology Devices (DHT3B)
Reproductive, Gynecology and Urology Devices (DHT3B)
Submission Type 510(k)
Regulation Number 884.1050
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons