510(k) K003587 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
CLEARGLIDE PRECISION BIPOLAR DEVICE
| Applicant | ETHICON, Inc., Somerville NJ, US |
| Decision | Substantially Equivalent, Dec 4, 2000 |
| Received | Nov 21, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003587
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 14, 2010 | Sorin Group USA, Inc. Sorin / Clearglide EVH Small, REF KTV15, Sterile R, Manufactured for: Sorin Group USA, Inc., 14401 W.65th Way, Arvada, CO 80004.
The device is indicated for endoscopic and open tissue dissection, bip Terminated |
GEI | None listed |
| Jan 14, 2010 | Sorin Group USA, Inc. Sorin / Clearglide EVH Low Profile, REF KTV16, Sterile R, Manufactured for: Sorin Group USA, Inc., 14401 W.65th Way, Arvada, CO 80004.
The device is indicated for endoscopic and open tissue dissectio Terminated |
GEI | None listed |
| Jan 14, 2010 | Sorin Group USA, Inc. Sorin / Clearglide EVH Small with Scissor, REF KTV17, Sterile R, Manufactured for: Sorin Group USA, Inc., 14401 W.65th Way, Arvada, CO 80004.
The device is indicated for endoscopic and open tissue di Terminated |
GEI | None listed |
| Jan 14, 2010 | Sorin Group USA, Inc. Sorin / Clearglide EVH Low Profile with Scissor, REF KTV18, Sterile R, Manufactured for: Sorin Group USA, Inc., 14401 W.65th Way, Arvada, CO 80004.
The device is indicated for endoscopic and open tis Terminated |
GEI | None listed |
| Jan 14, 2010 | Sorin Group USA, Inc. Sorin / Clearglide EVH Long View, REF KTV22, Sterile R, Manufactured for: Sorin Group USA, Inc., 14401 W.65th Way, Arvada, CO 80004.
The device is indicated for endoscopic and open tissue dissection, Terminated |
GEI | None listed |
| Jan 14, 2010 | Sorin Group USA, Inc. Sorin / Clearglide EVH Long View with Scissor, REF KTV23, Sterile R, Manufactured for: Sorin Group USA, Inc., 14401 W.65th Way, Arvada, CO 80004.
The device is indicated for endoscopic and open tissu Terminated |
GEI | None listed |
| Jan 14, 2010 | Sorin Group USA, Inc. Sorin / Clearglide Precision Bipolar, REF PBD01, Sterile R, Manufactured for: Sorin Group USA, Inc., 14401 W.65th Way, Arvada, CO 80004.
The device is indicated for endoscopic and open tissue dissect Terminated |
GEI | None listed |
| Aug 9, 2007 | Datascope Corporation Precision Bipolar Device
ClearGlide EVH Small (endoscopic vessel harvesting system)
The kit included three Precision BiPolar Devices, an Optical Vessel Dissector, a Small Ultra Retractor and a Vessel Terminated |
GEI | None listed |
| Aug 9, 2007 | Datascope Corporation The ClearGlide EVH small with Scissors.
The kit includes three Precision Bipolar Devices, an Optical Vessel Dissector, a Small Ultra Retractor, a Vessel Dissector, and the ENDOPATH 5mm curved scissors Terminated |
GEI | None listed |
| Aug 9, 2007 | Datascope Corporation Precision Bipolar Device 6 pack
Consists of a six-pack of the Precision Bipolar Device.
Manufactured for:
Datascope Cardiac Assist
15 Law Drive
Fairfield, NJ 07004-0011 Terminated |
GEI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.