{"data":{"id":"us/21-cfr-878.1800","jurisdiction":"us","citation":"21 CFR 878.1800","heading":"Speculum and accessories.","body":"(a) Identification. A speculum is a device intended to be inserted into a body cavity to aid observation. It is either nonilluminated or illuminated and may have various accessories.\n(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 878—GENERAL AND PLASTIC SURGERY DEVICES","Subpart B—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":"bc370167bc173209f299fb62f10ef69e5146900f156ec5dd32f410880354042d","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-878.9","next":"us/21-cfr-878.1820"},"notice":"GroundRules: Original legal text. Not legal advice."}