MicroCutter XCHANGE 30 Stapler, MicroCutter XCHANGE 30 Blue Cartridge, MicroCutter XCHANGE 30 White Cartridge
FDA 510(k) K151081 · Cardica, Inc.
510(k) numberK151081
Submission
- Device name
- MicroCutter XCHANGE 30 Stapler, MicroCutter XCHANGE 30 Blue Cartridge, MicroCutter XCHANGE 30 White Cartridge
- Applicant
- Cardica, Inc.
Redwood City, CA, US - Received
- April 22, 2015
- Decision date
- January 15, 2016
- 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 |
|---|---|---|
| K161137 | Dextera MicroCutter 5/80 Blue Reload, Dextera MicroCutter 5/80 Blue Curved Tip ReloadGDW · Traditional | 07/20/2016SE |
| K140118 | Microcutter Xchange 30 Stapler, Microcutter Xchange 30 Blue CartridgeGDW · Special | 02/25/2014SE |
| K140170 | Microcutter Xchange 30 Stapler, Microcutter Xchange 30 White CartridgeGDW · Special | 02/19/2014SE |
| 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 Blue Cartridge, MicroCutter XCHANGE 30 White Cartridge cleared by the FDA?
MicroCutter XCHANGE 30 Stapler, MicroCutter XCHANGE 30 Blue Cartridge, MicroCutter XCHANGE 30 White Cartridge (K151081) received a 510(k) decision of Substantially Equivalent on January 15, 2016, 268 days after the submission was received.
What is the product code of K151081?
The FDA product code is GDW – Staple, Implantable, a Class II (moderate risk) device regulated under 21 CFR 878.4750.