21 CFR §884.1060

1. (a)Identification. An endometrial aspirator is a device designed to remove materials from the endometrium (the mucosal lining of the uterus) by suction with a syringe, bulb and pipette, or catheter. This device is used to study endometrial cytology (cells).
2. (b)Classification. Class II. The special controls for this device are:
   1. (1)FDA's:
      1. (i)“Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ” and
      2. (ii)“510(k) Sterility Review Guidance of 2/12/90 (K90-1),”
   2. (2)Labeling:
      1. (i)Indication: Only to evaluate the endometrium, and
      2. (ii)Contraindications: Pregnancy, history of uterine perforation, or a recent cesarean section, and
   3. (3)The sampling component is covered within vagina.