ClearanceBrief
510(k) K050610 ยท GDW Staple, Implantable

SALUTE FIXATION SYSTEM

ApplicantDavol Inc., Sub. C. R. Bard, Inc., Canston RI, US
DecisionSubstantially Equivalent, May 25, 2005
ReceivedMar 10, 2005
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K050610

DateFirm and productCodeLinked 510(k)
Sep 27, 2007Davol, Inc., Sub. C. R. Bard, Inc.
Davol Salute Fixation Reusable Handle Item Code: 0113024-Product Code 9113024 (Refurbished)
Terminated		 GDWNone listed
Sep 27, 2007Davol, Inc., Sub. C. R. Bard, Inc.
Davol Salut Fixation Reusable 38cm Shaft (Laparoscopic) Item Numbers: 0113036-Product Code 9113036-(Refurbished)
Terminated		 GDWNone listed
Sep 27, 2007Davol, Inc., Sub. C. R. Bard, Inc.
Davol Salute Reusable 18cm Shaft (Short/Open) Item Numbers: 0113037-Product Code: 9113037(Refurbished)
Terminated		 GDWNone listed
Sep 27, 2007Davol, Inc., Sub. C. R. Bard, Inc.
Davol Salute Laproscopic 38cm Sterile Implant Cartridge, Sterile- 10 Q-ring;5/Box, Item Number: 0113058
Terminated		 GDWNone listed
Sep 27, 2007Davol, Inc., Sub. C. R. Bard, Inc.
Davol Salute Laproscopic 38cm Sterile Implant Cartridge, Sterile- 30 Q-ring;5/Box, Item Number: 0113035
Terminated		 GDWNone listed
Sep 27, 2007Davol, Inc., Sub. C. R. Bard, Inc.
Davol Salute Short 18cm Sterile Implant Cartridge - 10 Q-ring;5/Box, Item Number: 0113043
Terminated		 GWDNone listed
Feb 1, 2007Davol, Inc., Sub. C. R. Bard, Inc.
Davol Salute Fixation System, 38cm Reusable Shaft (Laparoscopic) with Handle. To attach mesh to the abdominal wall. Reference Number 0113036 or 9113036(refurbished)
Terminated		 GDWNone listed
Feb 1, 2007Davol, Inc., Sub. C. R. Bard, Inc.
Davol Salute Fixation System, 18cm Reusable Shaft (Short/Open) with Handle. To attach mesh to the abdominal wall. Reference Number 0113037 or 9113037(refurbished)
Terminated		 GDWNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.