Autosuture Endo Gia Staplers with Endo Gia Single Use Loading Units

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

510(k) Number

K083519 ↗

FDA Product Code

GDW

Device Class

Class II

Regulation

21 CFR Part 878.4750

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Sils Clincher, Sils Dissector, Sils Grasper, Sils L-Hook, Sils Shears

  Class II

  FDA 510(k) K091869 Active Cleared 1 Sep 2009

• Absorbatack 5mm Single Use Absorbable Fixation Device

  Class II

  FDA 510(k) K091900 Active Cleared 16 Jul 2009

• Sils Stitch Endoscopic Suturing Device

  Class II

  FDA 510(k) K090419 Active Cleared 9 Mar 2009

• Sils Port, Models SILSPT5, SILSPT12

  Class II

  FDA 510(k) K082619 Active Cleared 7 Nov 2008

• Modified Endo Stich

  Class II

  FDA 510(k) K082659 Active Cleared 19 Sep 2008

• Autosuture Versaport Plus Bladless Trocar; Bladeless Trocar

  Class II

  FDA 510(k) K081169 Active Cleared 23 May 2008

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• What types of surgical procedures are these staplers designed to assist with, and why is this important for minimally invasive surgery?

  The Autosuture Endo GIA Staplers are designed for endoscopic surgical procedures, specifically to facilitate resection, anastomosis, and dissection. These functions are critical in minimally invasive surgery because they allow surgeons to transect and divide tissue while simultaneously sealing cut edges with staples, reducing the need for open incisions and promoting faster recovery times.

• Are these staplers compatible with MRI environments, and how does this benefit the patient during surgery?

  Yes, these staplers are explicitly noted as compatible with MRI environments. This compatibility is beneficial because it allows for safer imaging during or after surgery without the risk of interference from metallic components, ensuring accurate diagnostic imaging and reducing potential complications.

• How are the Endo GIA Single-Use Loading Units packaged, and what does this mean for their use in a clinical setting?

  Each Endo GIA Single-Use Loading Unit is packaged individually and is sterile. This means they are ready for immediate use without reprocessing, reducing the risk of contamination and ensuring consistent performance. The single-use design also eliminates the need for cleaning and sterilization between procedures, streamlining workflow and improving efficiency in the operating room.

• What cartridge sizes and staple heights are available, and how might this variety benefit different surgical needs?

  The device comes in multiple configurations, including various staple heights and cartridge sizes such as 30mm, 45mm, and 60mm. This variety allows surgeons to select the appropriate size for different anatomical structures and surgical requirements, ensuring precise tissue approximation and sealing during procedures like resection or anastomosis.

• Since these staplers are intended for single-use, what considerations should a facility take into account when ordering or stocking them?

  Because these staplers are designed for single-use, facilities should ensure they order sufficient quantities to match anticipated surgical volume, accounting for different cartridge sizes and staple heights. Additionally, since they are pre-sterilized and individually packaged, storage should be in a clean, dry environment to maintain sterility until use, and proper inventory management will help avoid shortages during critical procedures.