21 C.F.R. § 884.1050   Endocervical aspirator.


Title 21 - Food and Drugs


Title 21: Food and Drugs
PART 884—OBSTETRICAL AND GYNECOLOGICAL DEVICES
Subpart B—Obstetrical and Gynecological Diagnostic Devices

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§ 884.1050   Endocervical aspirator.

(a) Identification. An endocervical aspirator is a device designed to remove tissue from the endocervix (mucous membrane lining the canal of the cervix of the uterus) by suction with a syringe, bulb and pipette, or catheter. This device is used to evaluate endocervical tissue to detect malignant and premalignant lesions.

(b) Classification. Class II (performance standards).

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