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Silk Sutures

by Lukens Corp.

PMA N80989

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

PMA N80989

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved 1 supplement NumberN80989 Date16 Mar 1988ApprovedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Specification

PMA

Generic Name
Suture, nonabsorbable, silk
PMA Number
FDA Product Code
GAP
Device Class
Class II
Regulation
21 CFR Part 878.5030
Advisory Committee
General, Plastic Surgery
FDA Decision
APPR Approved
PMA Supplement
S003 (Normal 180 Day Track)

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Silk Sutures are nonabsorbable sutures used for tissue approximation and ligation in surgical procedures. Made from natural silk fibers, they provide strength and flexibility for wound closure in various medical specialties, including general and plastic surgery.

These sutures are supplied sterile and intended for single-use. They are classified as Class II devices under FDA regulations and are authorized through a Premarket Approval (PMA). Available in multiple sizes and reference codes, they must be stored in a clean, dry environment to maintain sterility and integrity before use.

Other devices from Lukens Corp.

See all devices from Lukens Corp. →

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • Are Silk Sutures from Lukens Corp. reusable or intended for single-use only?

    Silk Sutures from Lukens Corp. are explicitly intended for single-use only. The device description confirms they are supplied sterile and designed to maintain sterility and integrity for one-time surgical use.

  • What storage conditions are required to keep Silk Sutures sterile and intact?

    To preserve sterility and integrity, Silk Sutures must be stored in a clean, dry environment. This prevents moisture or contamination that could compromise the suture’s performance before use.

  • How many different sizes or reference codes are available for Silk Sutures?

    Silk Sutures come in multiple sizes and reference codes, with over 100 unique FEI numbers listed in the specifications. These codes correspond to different suture gauges or configurations for various surgical needs.

  • What surgical specialties are Silk Sutures primarily used in?

    Silk Sutures are approved for use in general and plastic surgery, as indicated by the advisory committee description and medical specialty classification in the data.

  • What regulatory pathway was followed for the approval of Silk Sutures?

    Silk Sutures were authorized through a Premarket Approval (PMA) process by the FDA, as stated in the authorizations section. This pathway is typically used for higher-risk Class II devices requiring detailed evidence of safety and effectiveness.