Endo Gia Radial Reload with Tri-Staple Technology
FDA 510(k) K131705 · Covidien, Formerly US Surgical A Divison of Tyco H
510(k) numberK131705
Submission
- Device name
- Endo Gia Radial Reload with Tri-Staple Technology
- Applicant
- Covidien, Formerly US Surgical A Divison of Tyco H
North Haven, CT, US - Received
- June 11, 2013
- Decision date
- July 1, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|
| K130532 | Idrive Ultra Sterilization TrayKCT · Traditional | 05/30/2013SE |
| K130717 | Endo Gia ReloadGDW · Special | 04/18/2013SE |
| K130435 | Versaport V2 Bladeless Optical TrocarGCJ · Special | 03/14/2013SE |
| K122781 | Reliamax Gastrointestinal Anastomosis and ReloadGDW · Traditional | 02/05/2013SE |
| K123318 | Idrive Ultra Powered Handle and Endo Gia AdapterGDW · Special | 12/18/2012SE |
| K121510 | Idrive Ultra Powered Handle Endo Gia AdapterGDW · Traditional | 07/25/2012SE |
| K120061 | Wound ProtectorGCJ · Traditional | 03/27/2012SE |
| K120258 | Duet TRS Reloads, Duet TRS Reloads with Tri-Staple Technology, Endo Gia Universal and…GDW · Traditional | 02/29/2012SE |
| K111825 | Endo Gia(Tm) Staplers, DST Series(Tm) Gia(Tm) Staplers, DST Series(Tm) Ta(Tm) StaplersGDW · Traditional | 10/25/2011SE |
| K112349 | Versaport V2 Bladeless Optiical Trocar And/Or Versaport Bladeless Optical TrocarGCJ · Special | 09/01/2011SE |
Questions and answers
When was Endo Gia Radial Reload with Tri-Staple Technology cleared by the FDA?
Endo Gia Radial Reload with Tri-Staple Technology (K131705) received a 510(k) decision of Substantially Equivalent on July 1, 2013, 20 days after the submission was received.
What is the product code of K131705?
The FDA product code is GDW – Staple, Implantable, a Class II (moderate risk) device regulated under 21 CFR 878.4750.