21 CFR 886.4360

§ 886.4360 Ocular surgery irrigation device.

United States · 21 CFR — Food and Drugs · Status: effective

Cite this

Citation: 21 CFR 886.4360, § 886.4360 Ocular surgery irrigation device, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90989
Permanent ID: ys:prov:90989@1
SHA-256: 8f2028605cd3cd3d9bedd3d93a06b5bbbf1d901e029c289869f0b7642e3e0929

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Full text

(a) Identification. An ocular surgery irrigation device is a device intended to be suspended over the ocular area during ophthalmic surgery to deliver continuous, controlled irrigation to the surgical field. (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 § 886.9.

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.