{"data":{"id":"us/21-cfr-884.1060","jurisdiction":"us","citation":"21 CFR 884.1060","heading":"Endometrial aspirator.","body":"(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).\n(b) Classification. Class II. The special controls for this device are:\n(1) FDA's:\n(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ” and\n(ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),”\n(2) Labeling:\n(i) Indication: Only to evaluate the endometrium, and\n(ii) Contraindications: Pregnancy, history of uterine perforation, or a recent cesarean section, and\n(3) The sampling component is covered within vagina.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 884—OBSTETRICAL AND GYNECOLOGICAL DEVICES","Subpart B—Obstetrical and Gynecological Diagnostic Devices"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"62dfecc8d86f645a92fbe7b14a63bc3a7534e4b692d9073ba17755d9453ce9ed","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-884.1050","next":"us/21-cfr-884.1100"},"notice":"GroundRules: Original legal text. Not legal advice."}