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
| Code | Device | Records |
|---|---|---|
| GDW | Staple, Implantable | 21 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 23, 2009 | Surgical Devices/Covidien Power Supply -not sold separately, product code PWSP; Power Cord - Not sold separately, product code PWCD. Terminated |
GDW | None listed |
| Nov 23, 2009 | Surgical Devices/Covidien Device Sterilization Tray, product code T300. Terminated |
GDW | None listed |
| Nov 23, 2009 | Surgical Devices/Covidien Rigid Curved Positioner, product code RCP; Rigid Curved Positioner O-Ring, product code RCPOR. Terminated |
GDW | None listed |
| Nov 23, 2009 | Surgical 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 |
GDW | K091215 |
| Nov 23, 2009 | Surgical 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 |
GDW | K081826 |
| Nov 23, 2009 | Surgical Devices/Covidien Intelligent 60mm Straight Endoscopic Linear Cutter, product code i60S; Intelligent 60mm Straight Endoscopic Linear Cutter Reconditioned, product code i60SRC. Terminated |
GDW | K083527 |
| Nov 23, 2009 | Surgical Devices/Covidien Intelligent Delivery System, Straight, product code iDriveS; Intelligent Delivery System, Curved, product code iDriveC; Intelligent Delivery System, Flexible, product code iDriveF. Terminated |
GDW | K073001 |
| Nov 23, 2009 | Surgical 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 |
GDW | K071708 |
| Nov 23, 2009 | Surgical Devices/Covidien Program Memory Card, product code MCV1A. Terminated |
GDW | None listed |
| Nov 23, 2009 | Surgical Devices/Covidien Sterile Sheath, product code SS01. Terminated |
GDW | None listed |
| Nov 23, 2009 | Surgical Devices/Covidien Power Console, product code PC100; Power Console System, product code PC100S; Power Console Reconditioned, product code PC100RC. Terminated |
GDW | None listed |
| Nov 23, 2009 | Surgical 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 |
GDW | K040024 |
| Nov 23, 2009 | Surgical 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 |
GDW | None listed |
| Nov 23, 2009 | Surgical 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 |
GDW | None listed |
| Nov 23, 2009 | Surgical 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 |
GDW | K040720 |
| Nov 23, 2009 | Surgical 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 |
GDW | K021249 |
| Nov 23, 2009 | Surgical 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 |
GDW | K020719 |
| Nov 23, 2009 | Surgical Devices/Covidien Remote Control Unit with Wire, product code RCW100. Terminated |
GDW | K020343 |
| Nov 23, 2009 | Surgical 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 |
GDW | K021701 |
| Nov 23, 2009 | Surgical 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 |
GDW | K032701 |
| Nov 23, 2009 | Surgical 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 |
GDW | K003277 |