Microcutter Xchange 30 Stapler, Microcutter Xchange 30 White Cartridge
FDA 510(k) K140170 · Cardica, Inc.
510(k) numberK140170
Submission
- Device name
- Microcutter Xchange 30 Stapler, Microcutter Xchange 30 White Cartridge
- Applicant
- Cardica, Inc.
Redwood City, CA, US - Received
- January 23, 2014
- Decision date
- February 19, 2014
- 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 |
|---|---|---|
| K161137 | Dextera MicroCutter 5/80 Blue Reload, Dextera MicroCutter 5/80 Blue Curved Tip ReloadGDW · Traditional | 07/20/2016SE |
| K151081 | MicroCutter XCHANGE 30 Stapler, MicroCutter XCHANGE 30 Blue Cartridge, MicroCutter…GDW · Traditional | 01/15/2016SE |
| K140118 | Microcutter Xchange 30 Stapler, Microcutter Xchange 30 Blue CartridgeGDW · Special | 02/25/2014SE |
| K132581 | Microcutter Xchange 30, Microcutter Xchange 30, Blue Staple Cartridge, Blue Staple…GDW · Traditional | 01/07/2014SE |
| K101018 | Cardica C-Port Xa Plus Distal Anastomosis System, Model FG-000100FZP · Special | 06/25/2010SE |
| K091017 | Cardica Pas-Port Proximal Anastomosis System, Model FG-000001FZP · Special | 04/29/2009SE |
| K090872 | Modification to Cardica C-Port Xa Distal Anastomosis SystemFZP · Special | 04/21/2009SE |
| K081225 | Cardica Pas-Port Proximal Anastomosis SystemFZP · Traditional | 09/05/2008SE |
| K073304 | Cardica C-Port X-Change Anastomosis System and Handle and Xa X-Change SubassembliesFZP · Special | 12/20/2007SE |
| K073123 | Cardica C-Port Flex-A Distal Anastomosis System, Model FG-000150FZP · Special | 12/06/2007SE |
Questions and answers
When was Microcutter Xchange 30 Stapler, Microcutter Xchange 30 White Cartridge cleared by the FDA?
Microcutter Xchange 30 Stapler, Microcutter Xchange 30 White Cartridge (K140170) received a 510(k) decision of Substantially Equivalent on February 19, 2014, 27 days after the submission was received.
What is the product code of K140170?
The FDA product code is GDW – Staple, Implantable, a Class II (moderate risk) device regulated under 21 CFR 878.4750.