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510(k) Data Aggregation
K Number
K973415Device Name
CURVILINEAR SUTURE PLACEMENT SYSTEM
Manufacturer
Date Cleared
1997-12-02
(84 days)
Product Code
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
LAURUS MEDICAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Laurus Medical Curvilinear Suture Placement System is indicated for the placement of suture in a variety of Transvaginal procedures such as prolapse repair, cystourethropexy, and bladder neck stabilization; through Cooper's Ligament alone and/or in conjunction with non-device suturing procedures for the correction of urinary stress incontinence: for female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
Device Description
Curvilinear Suture Placement Device
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K Number
K973215Device Name
STEREOTACTIC NEEDLE CORE BIOPSY SYSTEM
Manufacturer
Date Cleared
1997-11-06
(71 days)
Product Code
Regulation Number
876.1075Why did this record match?
Applicant Name (Manufacturer) :
LAURUS MEDICAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Laurus Medical Stereotactic Needle Core Biopsy System is to be used in conjunction with Stereotactic Imaging Tables to obtain needle core biopsy samples from soft tissue percutaneously.
Device Description
Not Found
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K Number
K960317Device Name
LAURUS NEEDLE CORE BIOPSY SYSTEM
Manufacturer
Date Cleared
1996-03-15
(52 days)
Product Code
Regulation Number
876.1075Why did this record match?
Applicant Name (Manufacturer) :
LAURUS MEDICAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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