21 CFR 878.4680
§ 878.4680 Nonpowered, single patient, portable suction apparatus.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 878.4680, § 878.4680 Nonpowered, single patient, portable suction apparatus, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90449
- Permanent ID
ys:prov:90449@1- SHA-256
15f58be6de16f4ec29c988621bfe326e1e5980ecf4d34e7b0ab6665634c95623
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Full text
(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.
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.