Endo Gia Singleuse Duet Trs Reload with TRI0STAPLE Technology

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

510(k) Number

K103263 ↗

FDA Product Code

GDW

Device Class

Class II

Regulation

21 CFR Part 878.4750

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Reliamax Gastrointestinal Anastomosis and Reload

  Class II

  FDA 510(k) K122781 Active Cleared 5 Feb 2013

• Endo Gia(Tm) Staplers, Dst Series(Tm) Gia(Tm) Staplers, Dst Series(Tm) Ta(Tm) Staplers Open recall

  Class II

  FDA 510(k) K111825 Active Cleared 25 Oct 2011

• Duet Trs Reloads, Duet Trs Reloads with Tri-Staple Technology, Endo Gia Universal and Ultra Universal Staplers

  Class II

  FDA 510(k) K120258 Active Cleared 29 Feb 2012

• Idrive Ultra Powered Handle Endo Gia Adapter

  Class II

  FDA 510(k) K121510 Active Cleared 25 Jul 2012

• Endo Gia Radial Reload with Tri-Staple Technology

  Class II

  FDA 510(k) K131705 Active Cleared 1 Jul 2013

• Idrive Ultra Sterilization Tray

  Class II

  FDA 510(k) K130532 Active Cleared 30 May 2013

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• What is the Endo GIA Duet TRS Reload with Tri0Staple Technology used for?

  This reload is designed for laparoscopic surgeries to simultaneously divide tissue and apply two rows of triple-staggered titanium staples. The integrated absorbable reinforcement material enhances wound closure integrity, making it ideal for procedures requiring precise, reinforced stapling in general and plastic surgery.

• How is the Endo GIA Duet TRS Reload supplied, and is it sterile?

  The reload is supplied sterile and pre-packaged, ensuring readiness for immediate use in sterile surgical environments. This packaging guarantees sterility and safety, as it is intended for single-use only and must be discarded after deployment.

• Is the Endo GIA Duet TRS Reload with Tri0Staple Technology reusable?

  No, this reload is explicitly designed for single-use only. After deployment, it must be discarded to maintain sterility and safety standards, as reusing it could compromise patient safety and regulatory compliance.

• What surgical specialties commonly use this reload?

  The Endo GIA Duet TRS Reload is primarily intended for use in general and plastic surgery procedures. Its reinforced stapling technology is particularly useful in minimally invasive surgeries where secure tissue closure is critical.

• How is the regulatory status of this device determined?

  This device holds FDA 510(k) clearance under the classification of Class II medical devices, with a special decision code (SESE) indicating it is substantially equivalent to a predicate device. The clearance number is K103263, and it falls under the product code GDW for staple, implantable devices.