21 CFR § 878.5035 - Nonabsorbable expanded polytetrafluoroethylene surgical suture.
---
identifier: "/us/cfr/t21/s878.5035"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 878.5035 - Nonabsorbable expanded polytetrafluoroethylene surgical suture."
title_number: 21
title_name: "Food and Drugs"
section_number: "878.5035"
section_name: "Nonabsorbable expanded polytetrafluoroethylene surgical suture."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "878"
part_name: "GENERAL AND PLASTIC SURGERY DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "53 FR 23872, June 24, 1988, unless otherwise noted."
cfr_part: "878"
---
# 878.5035 Nonabsorbable expanded polytetrafluoroethylene surgical suture.
(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.
[65 FR 20735, Apr. 18, 2000, as amended at 68 FR 32985, June 3, 2003]