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U.S. Department of Health and Human Services

Product Classification
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Device at home intravaginal insemination system
Regulation Description Assisted reproduction catheters.
Definition To deliver semen to the vaginal canal for insemination.
Physical State The device consists of a syringe/catheter with or without a collection cup.
Technical Method A collection cup holds and contains semen or a sperm sample from a donor and works in conjunction with a syringe/catheter which withdraws the semen/sperm sample from the collection cup. The syringe is then used to deliver the semen/sperm sample to the vaginal canal.
Target Area Vaginal canal
Regulation Medical Specialty Obstetrics/Gynecology
Review Panel Obstetrics/Gynecology
Product CodeQYZ
Premarket Review Reproductive, Gynecology and Urology Devices (DHT3B)
Reproductive, Gynecology and Urology Devices (DHT3B)
Submission Type 510(k)
Regulation Number 884.6110
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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