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510(k) Data Aggregation
K Number
K162617Device Name
NobleStitch EL
Manufacturer
Date Cleared
2017-04-06
(198 days)
Product Code
Regulation Number
878.5010Why did this record match?
Applicant Name (Manufacturer) :
NOBLES MEDICAL TECHNOLOGIES II, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NobleStich EL is indicated for use in the placement of sutures for soft tissue approximation in cardiovascular procedures. The NobleStitch EL is not intended for blind vascular closure.
Device Description
The NobleStich EL device is a single-use surgical device, indicated for use in direct contact within the vascular and cardiovascular system. The NobleStitch EL device may be used by insertion through an access device (e.g. trocar, sheath or cannula), already in place following diagnostic or interventional procedures.
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K Number
K113494Device Name
NOBLESTITCH EL NOBLESTITCH MR NOBLESTITCH TA
Manufacturer
Date Cleared
2012-04-19
(146 days)
Product Code
Regulation Number
878.5010Why did this record match?
Applicant Name (Manufacturer) :
NOBLES MEDICAL TECHNOLOGIES II, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NobleStitch™ EL, MR, and TA sizes are indicated for use in performing vascular stitching in general surgery, including endoscopic procedures. The NobleStitch™ EL, MR, and TA are not intended for blind vascular closure.
Device Description
The NobleStitch™ EL, MR. and TA versions are hand-held and manually operated suturing devices designed to allow a physician to place a suture to a remote site either directly, through a cannula/introducer, or through a laparascopic access device. The device contains the following components and accessories: a suture delivery device, monofilament polypropylene suture, a KnotPusher™ accessory for advancing the knot to the wound site, and/or a KwiKnot™ accessory.
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K Number
K113763Device Name
SRM-STITCH 8F SRM-STITCH 8F WITH GUIDEWIRE
Manufacturer
Date Cleared
2012-03-16
(86 days)
Product Code
Regulation Number
878.5010Why did this record match?
Applicant Name (Manufacturer) :
NOBLES MEDICAL TECHNOLOGIES II, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SRM-Stitch™ 8F version is indicated for use in performing vascular stitching in general surgery, including endoscopic procedures. The SRM-Stitch™ 8F is not intended for blind vascular closure.
Device Description
The SRM-Stitch™ 8F version is hand-held and manually operated suturing devices designed to allow a physician to place a suture to a remote site either directly, through a cannula/introducer, or through a laparascopic access device. The device contains the following components and accessories: a suture delivery device, monofilament polypropylene suture, and a KwiKnot™ accessory. The optional KnotPusher™ accessory has been eliminated from current packaging configuration of SRM-Stitch™ 8F.
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