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U.S. Department of Health and Human Services

Product Classification
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Device cannula, injector, uterine, endometrial biopsy
Regulation Description Obstetric-gynecologic specialized manual instrument.
Definition to deliver saline and/or contrast media to complete saline infusion sonohysterography and/or hysterosalpingogram respectively and to obtain endometrial biopsy
Physical State cannula that allows injection of saline and/or contrast media and component that collects an endometrial biopsy sample
Technical Method inserted manually through the vagina and cervix and into the uterus; delivers saline and/or contrast media into the uterus and fallopian tubes, collects endometrial biopsy sample
Target Area uterus, fallopian tubes
Regulation Medical Specialty Obstetrics/Gynecology
Review Panel Obstetrics/Gynecology
Product CodePGK
Premarket Review Reproductive, Gynecology and Urology Devices (DHT3B)
Reproductive, Gynecology and Urology Devices (DHT3B)
Submission Type 510(k)
Regulation Number 884.4530
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 Not Third Party Eligible
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