21 CFR 878.4011
§ 878.4011 Tissue adhesive with adjunct wound closure device for topical approximation of skin.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 878.4011, § 878.4011 Tissue adhesive with adjunct wound closure device for topical approximation of skin, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90404
- Permanent ID
ys:prov:90404@1- SHA-256
6f30cf2452418f95ed9bcdb83bff627597fddb3ef1f3c6601a0590c35e9a8802
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Full text
(a) Identification. A tissue adhesive with adjunct wound closure device intended for the topical approximation of skin is a device indicated for topical application only to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations. It may be used in conjunction with, but not in place of, deep dermal stitches. Additionally, the adjunct wound closure device component maintains temporary skin edge alignment along the length of wound during application of the liquid adhesive.
(b) Classification. Class II (special controls). The special control for this device is FDA's “Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Tissue Adhesive with Adjunct Wound Closure Device Intended for the Topical Approximation of Skin.” 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.