21 CFR 874.3930
§ 874.3930 Tympanostomy tube with semipermeable membrane.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 874.3930, § 874.3930 Tympanostomy tube with semipermeable membrane, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90231
- Permanent ID
ys:prov:90231@1- SHA-256
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Full text
(a) Identification. A tympanostomy tube with a semipermeable membrane is a device intended to be implanted for ventilation or drainage of the middle ear and for preventing fluids from entering the middle ear cavity. The device is inserted through the tympanic membrane to permit a free exchange of air between the outer ear and middle ear. The tube portion of the device is made of silicone elastomer or porous polyethylene, and the membrane portion is made of polytetrafluoroethylene.
(b) Classification. Class II. The special control for this device is FDA's “Tympanostomy Tubes, Submission Guidance for a 510(k).”
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.