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Silk Nonabsorbable Sutures, USP

by Davis & Geck, Inc. 510(k)PMA

Active United States

PMA N84047510(k) K982853

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SN 510(k) Traditional NumberK982853 Date30 Apr 1999DecidedStatusActive
United StatesFDA PMA PMA 1 supplement NumberN84047 Date23 Jan 1981ApprovedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k), FDA PMA Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k) · PMA

Generic Name
Suture, nonabsorbable, silk
PMA Number
510(k) Number
FDA Product Code
GAP
Device Class
Class II
Regulation
21 CFR Part 878.5030
Advisory Committee
General, Plastic Surgery
FDA Decision
SN
PMA Supplement
S010

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.

The Silk Nonabsorbable Sutures, USP are nonabsorbable surgical sutures manufactured by Davis & Geck, Inc. These devices are designed to provide secure tissue approximation in various surgical procedures.

This product is identified under the generic name suture, nonabsorbable, silk and is associated with product code GAT. The device has received regulatory authorization through both FDA 510K and FDA PMA processes.

Other devices from Davis & Geck, Inc.

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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.

  • What type of material are these sutures made from?

    These are nonabsorbable sutures composed of silk, which is a natural protein fiber commonly used in surgical procedures for its handling characteristics.

  • Are these sutures intended to be absorbed by the body?

    No, these are classified as nonabsorbable sutures, meaning they are designed to maintain their tensile strength and remain in the tissue rather than being broken down by the body's metabolic processes.

  • What is the regulatory status of the Silk Nonabsorbable Sutures?

    The device has been cleared for use through the FDA 510K process and is also associated with an FDA PMA number, indicating it has met the necessary regulatory requirements for its classification.