21 CFR 878.4840

§ 878.4840 Absorbable polydioxanone surgical suture.

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

Cite this

Citation: 21 CFR 878.4840, § 878.4840 Absorbable polydioxanone surgical suture, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90468
Permanent ID: ys:prov:90468@1
SHA-256: 8feb35ba04b7ff7d7cbb728755cde86dc6a516eeb44987dd592c0d9f5327e704

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Full text

(a) Identification. An absorbable polydioxanone surgical suture is an absorbable, flexible, sterile, monofilament thread prepared from polyester polymer poly (p-dioxanone) and is intended for use in soft tissue approximation, including pediatric cardiovascular tissue where growth is expected to occur, and ophthalmic surgery. It may be coated or uncoated, undyed or dyed, and with or without a standard needle attached. (b) Classification. Class II (special controls). The special control for the device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.

Legislative history

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