ClearanceBrief
Company

Surgical Devices/Covidien

FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.

0510(k) clearances (0 in 12 months)
21recalls (0 in 12 months)
13recalls that name a 510(k)

Product codes

CodeDeviceRecords
GDWStaple, Implantable21

Latest 510(k) clearances

Decided510(k)Device and applicantCode
No clearances in this window.

Latest recalls

DateFirm and productCodeLinked 510(k)
Nov 23, 2009Surgical Devices/Covidien
Power Supply -not sold separately, product code PWSP; Power Cord - Not sold separately, product code PWCD.
Terminated
GDWNone listed
Nov 23, 2009Surgical Devices/Covidien
Device Sterilization Tray, product code T300.
Terminated
GDWNone listed
Nov 23, 2009Surgical Devices/Covidien
Rigid Curved Positioner, product code RCP; Rigid Curved Positioner O-Ring, product code RCPOR.
Terminated
GDWNone listed
Nov 23, 2009Surgical Devices/Covidien
Intelligent Battery Pack, product code iB100; Intelligent Battery Charger and Power Supply, product code iB1C1; Intelligent Battery Insertion Guide, product code iBIG-1; Intelligent Battery Insertion
Terminated
GDWK091215
Nov 23, 2009Surgical Devices/Covidien
Intelligent 60mm Articulating Endoscopic Linear Cutter, product code i60; Intelligent 60mm Articulating Endoscopic Linear Cutter Extra Long, product code i60XXL; Intelligent 45mm Articulating Endoscop
Terminated
GDWK081826
Nov 23, 2009Surgical Devices/Covidien
Intelligent 60mm Straight Endoscopic Linear Cutter, product code i60S; Intelligent 60mm Straight Endoscopic Linear Cutter Reconditioned, product code i60SRC.
Terminated
GDWK083527
Nov 23, 2009Surgical Devices/Covidien
Intelligent Delivery System, Straight, product code iDriveS; Intelligent Delivery System, Curved, product code iDriveC; Intelligent Delivery System, Flexible, product code iDriveF.
Terminated
GDWK073001
Nov 23, 2009Surgical Devices/Covidien
Intelligent Reload, 45 mm Blue, product code iR45B; Intelligent Reload, 45 mm Green, product code iR45G; Intelligent Reload Mid Cut 45mm Blue, product code iR45MB; Intelligent Reload Mid Cut 45mm Gree
Terminated
GDWK071708
Nov 23, 2009Surgical Devices/Covidien
Program Memory Card, product code MCV1A.
Terminated
GDWNone listed
Nov 23, 2009Surgical Devices/Covidien
Sterile Sheath, product code SS01.
Terminated
GDWNone listed
Nov 23, 2009Surgical Devices/Covidien
Power Console, product code PC100; Power Console System, product code PC100S; Power Console Reconditioned, product code PC100RC.
Terminated
GDWNone listed
Nov 23, 2009Surgical Devices/Covidien
Power Circular Stapler 21 mm Digital Loading Unit, product code PCS21; Power Circular Stapler 29 mm Digital Loading Unit, product code PCS29.
Terminated
GDWK040024
Nov 23, 2009Surgical Devices/Covidien
Endoscopic Linear Cutter Reload, 45 mm Blue, product code PLCR45B; Endoscopic Linear Cutter Reload, 45 mm Green, product code PLCR45G; Reusable Endoscopic Linear Cutter, 60 mm, product code PLC60; End
Terminated
GDWNone listed
Nov 23, 2009Surgical Devices/Covidien
Power Extender Straight, product code PES100; Power Extender Straight Reconditioned, product code PES100RC; Power Extender Curved with Integrated Controls Reconditioned, product code PEC200RC; Power E
Terminated
GDWNone listed
Nov 23, 2009Surgical Devices/Covidien
Power Linear Cutter 75 mm, Reusable Digital Loading Unit, product code PLC75; Power Linear Cutter Reload, 75 mm Blue, product code PLCR75B; Power Linear Cutter Reload, 75 mm Green, product code PLCR75
Terminated
GDWK040720
Nov 23, 2009Surgical Devices/Covidien
FlexShaft, product code FS14; FlexShaft II, product code FS214; FlexShaft III, product code FS312; FlexShaft III Sterilization Connector Guard, product code FS3SCG; FlexShaft II Reconditioned, product
Terminated
GDWK021249
Nov 23, 2009Surgical Devices/Covidien
Straight Linear Cutter 55 mm Blue Digital Loading Unit, product code SLC55B; Straight Linear Cutter 55 mm Green Digital Loading Unit, product code SLC55G; Straight Linear Cutter 55 mm Blue Reload, pro
Terminated
GDWK020719
Nov 23, 2009Surgical Devices/Covidien
Remote Control Unit with Wire, product code RCW100.
Terminated
GDWK020343
Nov 23, 2009Surgical Devices/Covidien
Right Angle Linear Cutter, 30 mm Digital Loading Unit, product code RALC30; Right Angle Linear Cutter, 30 mm Vascular Digital Loading Unit, product code RALC30V; Right Angle Linear Cutter, 45 mm Digit
Terminated
GDWK021701
Nov 23, 2009Surgical Devices/Covidien
Circular Stapler 21 mm Digital Loading Unit, product code CS21; Circular Stapler 25 mm Digital Loading Unit, product code CS25; Circular Stapler 29 mm Digital Loading Unit, product code CS29; Circular
Terminated
GDWK032701
Nov 23, 2009Surgical Devices/Covidien
SurgASSIST System Storage Cart, product code CART; SurgASSIST Service Manual, product code SRVM; SurgASSIST System Starter Kit, product code Surg200; SurgASSIST System with Integrated Controls, produc
Terminated
GDWK003277
Get alerts for these product codes