APPLE MEDICAL ONE-TOUCH UTERINE SAMPLER

K000026 · Apple Medical Corp. · HHK · Mar 31, 2000 · Obstetrics/Gynecology

Device Facts

Record IDK000026
Device NameAPPLE MEDICAL ONE-TOUCH UTERINE SAMPLER
ApplicantApple Medical Corp.
Product CodeHHK · Obstetrics/Gynecology
Decision DateMar 31, 2000
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 884.1175
Device ClassClass 2

Regulatory Classification

Identification

An endometrial suction curette is a device used to remove material from the uterus and from the mucosal lining of the uterus by scraping and vacuum suction. This device is used to obtain tissue for biopsy or for menstrual extraction. This generic type of device may include catheters, syringes, and tissue filters or traps.

Innolitics
510(k) Summary
Decision Summary
Classification Order
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