Skip to content

Ethicon Endosuture System

by Ethicon Inc.

510(k) K963329

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 NumberK963329 Date25 Oct 1996ClearedStatusActive

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  • Withdrawn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
GCJ
FDA applicant
ETHICON, Inc.
Device class
Class II
Regulation
21 CFR Part 876.1500
Advisory committee
Gastroenterology, Urology
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 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 Ethicon Endosuture System is a surgical suturing device classified as a suture set (Product Code: GCJ) under FDA nomenclature. It combines conventional suture materials with specialized needle configurations designed for endoscopic and minimally invasive procedures, facilitating precise tissue approximation in gastrointestinal and urological applications.

This system is supplied as a reusable surgical instrument paired with single-use sutures, including options such as Ethibond Excel 2-0 with EN-3 needles, available in loop or pre-tied configurations. Sterility is maintained via terminal sterilization, and the device is intended for use in controlled surgical environments. Authorized under FDA 510(k) clearance (K963329), it adheres to traditional review standards and is distributed in sterile packaging, with each unit containing 12 sutures per box.

Other devices from Ethicon Inc.

See all devices from Ethicon Inc. →

Questions

AI-generated answers, 19 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 Ethicon Endosuture System used for?

    The Ethicon Endosuture System is a surgical suturing device designed for endoscopic and minimally invasive procedures, facilitating precise tissue approximation in gastrointestinal and urological applications.

  • How is the Ethicon Endosuture System supplied?

    The system is supplied as a reusable surgical instrument paired with single-use sutures, including options such as Ethibond Excel 2-0 with EN-3 needles, available in loop or pre-tied configurations, with 12 sutures per box.

  • Is the Ethicon Endosuture System sterile?

    Yes, sterility is maintained via terminal sterilization, and the device is distributed in sterile packaging for use in controlled surgical environments.

  • What are the regulatory approvals for the Ethicon Endosuture System?

    The device is authorized under FDA 510(k) clearance (K963329) and classified as a suture set (Product Code: GCJ) under FDA nomenclature, adhering to traditional review standards.