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Found 9 results
510(k) Data Aggregation
K Number
K980123Device Name
CARTER-THOMASON NEEDLE-POINT SUTURE PASSER INSTRUMENT SET
Manufacturer
LOUISVILLE LABORATORIES, INC.
Date Cleared
1998-03-09
(54 days)
Product Code
GCJ
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
LOUISVILLE LABORATORIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Needle-Point Suture Passer is indicated to pass suture through soft tissues of the body during endoscopic/laparoscopic surgery.
Device Description
Needle-Point Suture Passer Instrument Set
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K Number
K971796Device Name
LAPAROTOMY BLADDER NECK SUSPENSION KIT WITH BONE ANCHORS
Manufacturer
LOUISVILLE LABORATORIES, INC.
Date Cleared
1997-08-12
(89 days)
Product Code
EZL, HET, HWC, MBI
Regulation Number
876.5130Why did this record match?
Applicant Name (Manufacturer) :
LOUISVILLE LABORATORIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Louisville Laboratories, Inc. Laparotomy Bladder Neck Suspension Kit With Bone Anchors is intended for bladder neck suspension for female stress incontinence due to urethral hypermobility.
Device Description
The Laparotomy Bladder Neck Suspension Kit With Bone Anchors is comprised of a template assembly, suture retriever, suture cutter, bone anchors and suture pulling loop. The template assembly, suture retriever and suture cutter were cleared for marketing on April 4, 1997 under K963076, as part of the Louisville Laboratories Laparoscopic Bone Anchored Urethropexy Instrument Tray.
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K Number
K971791Device Name
VAGINAL SUTURING KIT FOR LAPAROTOMY BLADDER NECK SUSPENSION
Manufacturer
LOUISVILLE LABORATORIES, INC.
Date Cleared
1997-07-30
(76 days)
Product Code
MBI
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
LOUISVILLE LABORATORIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Louisville Laboratories, Inc. Vaginal Suturing Kit for Laparobomy Bladder Neck Suspension is indicated for urethropexy procedures for bladder neck suspension to correct incontinence due to urethral hypermobility.
Device Description
The Laparotomy Bladder Neck Suspension Kit is comprised of a template assembly, suture retriever, suture cutter and suture pulling loop. The template assembly, suture retriever and suture cutter were cleared for marketing on April 4, 1997 under K963076, as part of the Louisville Laboratories Laparoscopic Bone Anchored Urethropexy Instrument Tray.
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K Number
K971802Device Name
VAGINAL SUTURING KIT FOR BLADDER NECK SUSPENSION
Manufacturer
LOUISVILLE LABORATORIES, INC.
Date Cleared
1997-07-30
(76 days)
Product Code
MBI
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
LOUISVILLE LABORATORIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Louisville Laboratories, Inc. Vaginal Suturing Kit for Laparoscopic Bladder Neck Suspension is intended for bladder neck suspension for female stress incontinence due to urethral hypermobility.
Device Description
The Vaginal Suturing Kit for Laparoscopic Bladder Neck Suspension is comprised of a template assembly, suture retriever, and suture cutter. The template assembly, suture retriever and suture cutter were cleared for marketing on April 4, 1997 under K963076, as part of the Louisville Laboratories Laparoscopic Bone Anchored Urethropexy Instrument Tray.
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K Number
K971797Device Name
LAPAROSCOPIC BLADDER NECK SUSPENSION KIT
Manufacturer
LOUISVILLE LABORATORIES, INC.
Date Cleared
1997-07-22
(68 days)
Product Code
HET
Regulation Number
884.1720Why did this record match?
Applicant Name (Manufacturer) :
LOUISVILLE LABORATORIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Louisville Laboratories, Inc. Laparoscopic Bladder Neck Suspension Kit is all intended for bladder neck suspension for female stress incontinence due to urethral hypermobility.
The Louisville Laboratories, Inc. Laparoscopic Bladder Neck Suspension Kit is indicated for urethropexy procedures for bladder neck suspension to correct female stress incontinence due to urethral hypermobility.
Device Description
The Laparoscopic Bladder Neck Suspension Kit is comprised of a template assembly, suture retriever, and suture cutter and suture placement system. The template assembly, suture retriever and suture cutter were cleared for marketing on April 4, 1997 under K963076, as part of the Louisville Laboratories Laparoscopic Bone Anchored Urethropexy Instrument Tray. The suture placement system that is offered in the kit is the Laurus Medical Disposable Suture Placement System.
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K Number
K971801Device Name
LAPAROTOMY BLADDER NECK SUSPENSION KIT
Manufacturer
LOUISVILLE LABORATORIES, INC.
Date Cleared
1997-07-22
(68 days)
Product Code
EZL
Regulation Number
876.5130Why did this record match?
Applicant Name (Manufacturer) :
LOUISVILLE LABORATORIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Louisville Laboratories, Inc. Laparotomy Bladder Neck Suspension Kit is all intended for bladder neck suspension for female stress incontinence due to urethral hypermobility.
Device Description
The Laparotomy Bladder Neck Suspension Kit is comprised of a template assembly, suture retriever, and suture cutter and suture placement system. The template assembly, suture retriever and suture cutter were cleared for marketing on April 4, 1997 under K963076, as part of the Louisville Laboratories Laparoscopic Bone Anchored Urethropexy Instrument Tray. The suture placement system that is offered is the Laurus Medical Disposable Suture Placement System.
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K Number
K963076Device Name
LAPAROSCOPIC BONE ANCHORED URETHROPEXY INSTRUMENT TRAY
Manufacturer
LOUISVILLE LABORATORIES, INC.
Date Cleared
1997-04-04
(240 days)
Product Code
HET, EZL, JDR
Regulation Number
884.1720Why did this record match?
Applicant Name (Manufacturer) :
LOUISVILLE LABORATORIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K960882Device Name
CONTROL SYRINGE
Manufacturer
LOUISVILLE LABORATORIES, INC.
Date Cleared
1996-07-08
(139 days)
Product Code
FMF
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
LOUISVILLE LABORATORIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K955535Device Name
LOUISVILLE LABS OXYGEN HEAD TENT
Manufacturer
LOUISVILLE LABORATORIES, INC.
Date Cleared
1996-07-01
(209 days)
Product Code
CBF
Regulation Number
868.5470Why did this record match?
Applicant Name (Manufacturer) :
LOUISVILLE LABORATORIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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