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Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures; Force Fiber OrthoTape suture; Bondek suture and Bondek Plus suture; Monodek suture; Polyglytone*6211 suture

by Teleflex Medical Incorporated

510(k) K181774

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK181774 Date10 Oct 2018ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
GAT
Models / Variants
Device Class
Class II
Regulation
21 CFR Part 878.5000
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

This device is a suite of surgical sutures for soft tissue approximation and ligation. It includes non-absorbable UHMWPE variants (Force Fiber and OrthoTape) and absorbable synthetic variants (Bondek, Bondek Plus, Monodek, and Polyglytone*6211).

The sutures are provided sterile via ethylene oxide (EO) and are single-use. They are available in various USP sizes, colors, and needle attachments for use by surgeons in operating room (OR) settings. The device received FDA 510(k) clearance (K181774) and is classified under product code GAT.

Other devices from Teleflex Medical Incorporated

Questions

AI-generated answers, 1 Oct 2026

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

  • What is this suture suite used for?

    This device is a suite of surgical sutures designed for soft tissue approximation and ligation in operating room settings, used by surgeons to close or tie tissues during procedures.

  • How are these sutures supplied and are they sterile?

    The sutures are provided sterile via ethylene oxide (EO) sterilization and are intended for single-use only, ensuring they are free from microbial contamination at the point of use.

  • What types of sutures are included in this suite?

    The suite includes non-absorbable UHMWPE variants (Force Fiber and OrthoTape) and absorbable synthetic variants (Bondek, Bondek Plus, Monodek, and Polyglytone*6211 suture), offering options for different tissue healing timelines.

  • What sizes and configurations are available?

    The sutures are available in various USP sizes, multiple colors (including white, white/blue, white/black, blue, and white/green), and with different needle attachments to suit diverse surgical needs.

  • What regulatory pathway was used for this device?

    The device received FDA 510(k) clearance under submission K181774, demonstrating it is substantially equivalent to a legally marketed predicate device.