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510(k) Data Aggregation
K Number
K010936Device Name
MODIFICATION TO SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL
Manufacturer
W.L. GORE & ASSOCIATES,INC
Date Cleared
2001-05-21
(54 days)
Product Code
OXD
Regulation Number
878.3300Why did this record match?
Product Code :
OXD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K001789Device Name
SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL
Manufacturer
W.L. GORE & ASSOCIATES,INC
Date Cleared
2000-07-06
(23 days)
Product Code
OXD
Regulation Number
878.3300Why did this record match?
Product Code :
OXD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K955364Device Name
SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL
Manufacturer
W.L. GORE & ASSOCIATES,INC
Date Cleared
1996-02-01
(71 days)
Product Code
OXD, FTL
Regulation Number
878.3300Why did this record match?
Product Code :
OXD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is intended for use as a prosthesis for the surgical repair of soft tissue deficiencies using linear surgical staplers. The device can be used to reinforce staple lines during lung resections, abdominal and thoracic wall repairs, gastric banding, muscle flap reinforcement, repairs, vaginal prolanse, maluing il vaginal prolapse, pelvic floor reconstruction, urethral sling and diaphragmatic, femoral, incisional, incisional, inguinal, lumbar, paracolostomy, scrotal, and umbilical hernial, The device may be used with anastomotic staplers and with non-anastomotic staplers.
Device Description
Biocompatible, expanded polytetrafluoroethylene (ePTFE) in sleeve form. The sleeve is configured for use with commercially available linear surgical stapless
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