Auto Suture Endo Gia Staplers with Endo Gia Single Use Loading Units with Staple Line Reinforcement
FDA 510(k) K080898 · Tyco Healthcare Group LP
510(k) numberK080898
Submission
- Device name
- Auto Suture Endo Gia Staplers with Endo Gia Single Use Loading Units with Staple Line Reinforcement
- Applicant
- Tyco Healthcare Group LP
North Haven, CT, US - Received
- March 31, 2008
- Decision date
- May 5, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GDW – Staple, Implantable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4750
- Specialty
- General, Plastic Surgery
- Implant
- Yes
Other 510(k)s with product code GDW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260196 | ETHICON Circular Stapler (CDH21mm); ETHICON Circular Stapler (CDH25mm); ETHICON…GDW · Traditional | Ethicon Endo-Surgery, LLC | 05/11/2026SE |
| K253657 | Tri-staple 2.0 Reloads; Endo GIA Reloads with Tri-Staple Technology; Endo GIA Gray…GDW · Traditional | Covidien (Part of Medtronic) | 04/10/2026SE |
| K252739 | ETHICON 4000 45mm Compact Stapler (EC3DT45C); ETHICON 4000 45mm Standard Stapler…GDW · Traditional | Ethicon Endo-Surgery, LLC | 12/17/2025SE |
| K250835 | ETHICON 4000 60mm Compact Stapler (EC3D60C); ETHICON 4000 60mm Standard Stapler…GDW · Traditional | Ethicon Endo-Surgery, LLC | 05/14/2025SE |
| K243276 | ECHELON LINEAR Stapler 30mm Stapler (GTX30); ECHELON LINEAR Stapler 60mm Stapler…GDW · Traditional | Ethicon Endo-Surgery, LLC | 02/25/2025SE |
| K241630 | ECHELON 4000 60mm Compact Stapler (EC3D60C); ECHELON 4000 60mm Standard Stapler…GDW · Traditional | Ethicon Endo-Surgery, LLC | 10/28/2024SE |
| K242679 | Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (30mm…GDW · Special | Fengh Medical Co., Ltd. | 10/04/2024SE |
| K222487 | Anika Tissue Tack Fixation SystemGDW · Traditional | Anika Therapeutics, Inc. | 05/08/2023SE |
| K222210 | AEON Endoscopic StaplerGDW · Traditional | Lexington Medical, Inc. | 04/21/2023SE |
| K223760 | ECHELON LINEAR 60 mm Cutter (GLC60);ECHELON LINEAR 80mm Cutter (GLC80);ECHELON LINEAR…GDW · Traditional | Ethicon Endo-Surgery | 03/15/2023SE |
More from Ethicon Endo-Surgery
| 510(k) | Device | Decision |
|---|---|---|
| K071371 | Copa Amd Antimicrobial Wound DressingFRO · Traditional | 11/19/2007SE |
| K063536 | Polysorb* Synthetic Absorbable Suture with Modified PackagingGAM · Traditional | 01/29/2007SE |
| K060509 | Palindrome Emerald 14.5 FR Chronic Hemodialysis Catheter with Heparin CoatingNYU · Traditional | 06/23/2006SE |
| K060649 | Genius 2 Infrared Tympanic Electronic Thermometer, Model 303000FLL · Traditional | 05/22/2006SE |
| K010909 | Nonabsorbable Polypropylene Surgical SutureGAW · Special | 04/09/2001SE |
Questions and answers
When was Auto Suture Endo Gia Staplers with Endo Gia Single Use Loading Units with Staple Line Reinforcement cleared by the FDA?
Auto Suture Endo Gia Staplers with Endo Gia Single Use Loading Units with Staple Line Reinforcement (K080898) received a 510(k) decision of Substantially Equivalent on May 5, 2008, 35 days after the submission was received.
What is the product code of K080898?
The FDA product code is GDW – Staple, Implantable, a Class II (moderate risk) device regulated under 21 CFR 878.4750.