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U.S. Department of Health and Human Services

Product Classification

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Device instrument, biopsy, core, soft tissue, female reproductive organs
Definition Obtain core soft tissue biopsy samples of internal female reproductive organs such as uterus, ovaries, and retroperitoneal lymph nodes.
Physical State Metal needle and cannula.
Technical Method Manual rotation of needle and cannula to remove soft tissue for biopsy samples.
Target Area Internal female reproductive organs (uterus, ovaries, retroperitoneal lymph nodes.
Regulation Medical Specialty Gastroenterology/Urology
Review Panel Obstetrics/Gynecology
Product CodeQHC
Premarket Review Reproductive, Gynecology and Urology Devices (DHT3B)
Reproductive, Gynecology and Urology Devices (DHT3B)
Submission Type 510(k)
Regulation Number 876.1075
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 Not Third Party Eligible