Endo Gia(Tm) Staplers, DST Series(Tm) Gia(Tm) Staplers, DST Series(Tm) Ta(Tm) Staplers
FDA 510(k) K111825 · Covidien, Formerly US Surgical A Divison of Tyco H
510(k) numberK111825
Submission
- Device name
- Endo Gia(Tm) Staplers, DST Series(Tm) Gia(Tm) Staplers, DST Series(Tm) Ta(Tm) Staplers
- Applicant
- Covidien, Formerly US Surgical A Divison of Tyco H
North Haven, CT, US - Received
- June 28, 2011
- Decision date
- October 25, 2011
- 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 |
|---|---|---|
| K131705 | Endo Gia Radial Reload with Tri-Staple TechnologyGDW · Special | 07/01/2013SE |
| 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 |
| K112349 | Versaport V2 Bladeless Optiical Trocar And/Or Versaport Bladeless Optical TrocarGCJ · Special | 09/01/2011SE |
Questions and answers
When was Endo Gia(Tm) Staplers, DST Series(Tm) Gia(Tm) Staplers, DST Series(Tm) Ta(Tm) Staplers cleared by the FDA?
Endo Gia(Tm) Staplers, DST Series(Tm) Gia(Tm) Staplers, DST Series(Tm) Ta(Tm) Staplers (K111825) received a 510(k) decision of Substantially Equivalent on October 25, 2011, 119 days after the submission was received.
What is the product code of K111825?
The FDA product code is GDW – Staple, Implantable, a Class II (moderate risk) device regulated under 21 CFR 878.4750.