21 CFR 886.4790
§ 886.4790 Ophthalmic sponge.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 886.4790, § 886.4790 Ophthalmic sponge, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/91002
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Full text
(a) Identification. An ophthalmic sponge is a device that is an absorbant sponge, pad, or spear made of folded gauze, cotton, cellulose, or other material intended to absorb fluids from the operative field in ophthalmic surgery.
(b) Classification. Class II (special 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.