{"data":{"id":"us/21-cfr-878.4680","jurisdiction":"us","citation":"21 CFR 878.4680","heading":"Nonpowered, single patient, portable suction apparatus.","body":"(a) Identification. A nonpowered, single patient, portable suction apparatus is a device that consists of a manually operated plastic, disposable evacuation system intended to provide a vacuum for suction drainage of surgical wounds.\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 § 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 E—Surgical 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":"083176b330065d95072d229a438541df3020ec0395066b7f31610c08ab04ef98","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-878.4675","next":"us/21-cfr-878.4683"},"notice":"GroundRules: Original legal text. Not legal advice."}