21 CFR 878.5035

§ 878.5035 Nonabsorbable expanded polytetrafluoroethylene surgical suture.

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

Cite this

Citation: 21 CFR 878.5035, § 878.5035 Nonabsorbable expanded polytetrafluoroethylene surgical suture, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90480
Permanent ID: ys:prov:90480@1
SHA-256: a25e189c24f488eb203cf692f8f6012722ab851ed408d6896975c9a8e658f87b

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Full text

(a) Identification. Nonabsorbable expanded polytetrafluoroethylene (ePTFE) surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from ePTFE and is intended for use in soft tissue approximation and ligation, including cardiovascular surgery. It may be undyed or dyed with an approved color additive and may be provided with or without an attached needle(s). (b) Classification. Class II (special controls). The special control for this 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.