MICROCUTTER XCHANGE 30, MICROCUTTER XCHANGE 30, BLUE STAPLE CARTRIDGE, BLUE STAPLE CARTRIDGE— 510(k) K132581

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

2013-08-16

Decision date

2014-01-07

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Redwood City, CA, US

• K260196 — ETHICON Circular Stapler (CDH21mm) +7 more2026-05-11
• K253657 — Tri-staple 2.0 Reloads +3 more2026-04-10
• K252739 — ETHICON 4000 45mm Compact Stapler (EC3DT45C) +6 more2025-12-17
• K250835 — ETHICON 4000 60mm Compact Stapler (EC3D60C) +6 more2025-05-14
• K243276 — ECHELON LINEAR Stapler 30mm Stapler (GTX30) +8 more2025-02-25

• K161137 — Dextera MicroCutter 5/80 Blue Reload, Dextera MicroCutter 5/80 Blue Curved Tip Reload2016-07-20
• K151081 — MicroCutter XCHANGE 30 Stapler, MicroCutter XCHANGE 30 Blue Cartridge, MicroCutter XCHANGE 30 White Cartridge2016-01-15
• K140118 — MICROCUTTER XCHANGE 30 STAPLER, MICROCUTTER XCHANGE 30 BLUE CARTRIDGE2014-02-25
• K140170 — MICROCUTTER XCHANGE 30 STAPLER, MICROCUTTER XCHANGE 30 WHITE CARTRIDGE2014-02-19
• K101018 — CARDICA C-PORT XA PLUS DISTAL ANASTOMOSIS SYSTEM, MODEL FG-0001002010-06-25

Death

450

Injury

12,684

Malfunction

68,730

Other

6

Total

81,870

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-0482-2016 — MicroCutter Xchange 30 Blue Cartridge, FG-025320; The MicroCutter XCHANGE 30 Blue Cartridge and MicroCutter XCHANGE 30 Blue Curved Tip Cartridge contain 316L stainless steel staples. The cartridges are used with the MicroCutter XCHANGE 30 Stapler, which is a single patient device. When the MicroCutter XCHANGE 30 Stapler is loaded with a MicroCutter XCHANGE 30 Cartridge, two double rows of 316L stainless steel staples are delivered while simultaneously transecting tissue between the two, double staple rows. The MicroCutter XCHANGE 30 Stapler and MicroCutter XCHANGE 30 Cartridge are designed for introduction and use through a 5mm trocar cannula or larger. Intended for use in multiple open or minimally invasive surgical procedures for the transaction, resection, and /or creation of anastomoses in small and large intestine as well as the transection of the appendix.Class II·Terminated·Cardica, Inc.·20151106

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K132581.