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510(k) Data Aggregation
K Number
K982042Device Name
ISLAND BIOSURGICAL BLADDER NECK BOLSTR MODEL IBIBOL.002
Manufacturer
Date Cleared
1998-09-08
(90 days)
Product Code
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
ISLAND BIOSURGICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Island Biosurgical, Inc. Bladder Neck Suspension Bolster is to be used by operating pelvic surgeons to surgically correct female stress urinary incontinence due to pelvic relaxation. This bolster is recommended where the possibility of reduced suture and mosh reaction is desired.
Device Description
A surgically implantable polypropylene mesh bolster with monofilament sutures.
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K Number
K973022Device Name
ISLAND BIOSURGICAL INC. BNS KIT #1 & #2
Manufacturer
Date Cleared
1997-10-20
(67 days)
Product Code
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
ISLAND BIOSURGICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Island Biosurgical, Inc. Bladder Neck Suspension Kit is to be used by operating pelvic surgeons to surgically correct female stress urinary incontinence due to pelvic relaxation.
Device Description
A surgical kit including disposable surgical suture carriers and catheter stylet, implantable polypropylene mesh bolsters, a urethral Malecot catheter, surgical drapes, with bone anchors (Kit #2) or without bone anchors (Kit #1).
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K Number
K960101Device Name
ISLAND BIOSURGICAL BOLSTER
Manufacturer
Date Cleared
1996-12-16
(340 days)
Product Code
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
ISLAND BIOSURGICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Supporting the endopelvic fascia in bladder neck surgery for stress incontinence.
The Island Biosurgical Bolster is indicated for correction of pelvic floor relaxation or herniation at the bladder neck level.
Device Description
A preformed surgical mesh device with sutures woven along the edges.
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