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U.S. Department of Health and Human Services

Product Classification

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Device sampler, endocervical
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