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Quill Pdo Knotless Tissue-Closure Device

by Angiotech

510(k) K113744

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 NumberK113744 Date1 Feb 2012ClearedStatusActive

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  • Withdrawn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)

Full name
Quill Pdo Knotless Tissue-Closure Device (Polydioxanone)
510(k) Number
FDA Product Code
NEW
Device Class
Class II
Regulation
21 CFR Part 878.4840
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 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 Quill Pdo Knotless Tissue-Closure Device is a synthetic absorbable surgical suture composed of polydioxanone monofilament. It is designed for soft tissue approximation where the use of an absorbable suture is appropriate, featuring uni-directional barbs along its length.

This device is classified as a Class II absorbable surgical suture under regulation number 878.4840. It is authorized for use via FDA 510(k) clearance.

Other devices from Angiotech

Questions

AI-generated answers, 23 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 is the primary clinical use for the Quill PDO Knotless Tissue-Closure Device?

    This device is indicated for the approximation of soft tissue in surgical procedures where the use of an absorbable suture is deemed appropriate by the clinician.

  • How does the design of this suture differ from traditional options?

    The Quill PDO device features uni-directional barbs along its length, which allows for tissue closure without the need for traditional knots.

  • What material is used to manufacture this suture?

    The device is composed of polydioxanone, which is a synthetic absorbable monofilament material designed to be broken down by the body over time.

  • What is the regulatory status of this device?

    The Quill PDO Knotless Tissue-Closure Device is authorized for use via FDA 510(k) clearance under regulation number 878.4840 as a Class II absorbable surgical suture.