Dextera MicroCutter 5/80 Blue Reload, Dextera MicroCutter 5/80 Blue Curved Tip Reload— 510(k) K161137
Substantially EquivalentCardica, Inc.
FDA 510(k) clearance K161137 for Dextera MicroCutter 5/80 Blue Reload, Dextera MicroCutter 5/80 Blue Curved Tip Reload, Substantially Equivalent on 2016-07-20. 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- K151081 — MicroCutter XCHANGE 30 Stapler, MicroCutter XCHANGE 30 Blue Cartridge, MicroCutter XCHANGE 30 White Cartridge
- 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.