MicroCutter XCHANGE 30 Stapler, MicroCutter XCHANGE 30 Blue Cartridge, MicroCutter XCHANGE 30 White Cartridge— 510(k) K151081
Substantially EquivalentCardica, Inc.
FDA 510(k) clearance K151081 for MicroCutter XCHANGE 30 Stapler, MicroCutter XCHANGE 30 Blue Cartridge, MicroCutter XCHANGE 30 White Cartridge, Substantially Equivalent on 2016-01-15. Applicant: Cardica, Inc.. Device class: 2.
Clearance details
- Applicant
- Cardica, Inc.
- Product code
- Code GDW
- Device class
- Class 2
- Regulation
- 21 CFR 878.4750
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Redwood City, CA, US
Recent devices under product code GDW
view allMore clearances from Cardica, Inc.
view all- K161137 — Dextera MicroCutter 5/80 Blue Reload, Dextera MicroCutter 5/80 Blue Curved Tip Reload
- K140118 — MICROCUTTER XCHANGE 30 STAPLER, MICROCUTTER XCHANGE 30 BLUE CARTRIDGE
- K140170 — MICROCUTTER XCHANGE 30 STAPLER, MICROCUTTER XCHANGE 30 WHITE CARTRIDGE
- K132581 — MICROCUTTER XCHANGE 30, MICROCUTTER XCHANGE 30, BLUE STAPLE CARTRIDGE, BLUE STAPLE CARTRIDGE
- K101018 — CARDICA C-PORT XA PLUS DISTAL ANASTOMOSIS SYSTEM, MODEL FG-000100
Adverse events under product code GDW
product code GDW- Death
- 450
- Injury
- 12,684
- Malfunction
- 68,730
- Other
- 6
- Total
- 81,870
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.