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510(k) Data Aggregation
K Number
K120831Device Name
ANCHORSURE
Manufacturer
NEOMEDIC INTERNATIONAL S.L.
Date Cleared
2012-10-12
(207 days)
Product Code
PBQ
Regulation Number
884.4530Why did this record match?
Applicant Name (Manufacturer) :
NEOMEDIC INTERNATIONAL S
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Anchorsure is indicated for attaching suture to ligaments of the pelvic floor
Device Description
Anchorsure is a suture kit that consists of monofilament polypropylene suture, an anchor, an anchoring handle, and a surgical needle.
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K Number
K103022Device Name
KIM
Manufacturer
NEOMEDIC INTERNATIONAL S.L.
Date Cleared
2011-12-20
(434 days)
Product Code
OTN
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
NEOMEDIC INTERNATIONAL S
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
KIM (Knotless Incontinence Mesh) is a surgical mesh kit for treatment of female stress urinary incontinence resulting from urethral hyper mobility and / or intrinsic sphincter deficiency.
Device Description
KIM (Knotless Incontinence Mesh) is a sterile, single use surgical mesh kit for the treatment of female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency. KIM (Knotless Incontinence Mesh) is composed by a monofilament polypropylene mesh sling and two passers used to pass the sling through the obturator foramens. Polypropylene monofilament traction threads are fixed at each end of the mesh to facilitate the attachment of the passers to the mesh. The passers are used to deliver the sling via the trans-obturator "out-inside" approach. The traction threads are removed after placement of the sling. When placing the mesh, the sling can be adjusted by the surgeon to leave the mesh flat under the urethra, at the proper tension providing extra support to the urethra.
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K Number
K102815Device Name
SURELIFT PROLAPSE SYSTEM
Manufacturer
NEOMEDIC INTERNATIONAL
Date Cleared
2011-07-07
(282 days)
Product Code
OTP
Regulation Number
884.5980Why did this record match?
Applicant Name (Manufacturer) :
NEOMEDIC INTERNATIONAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SURELIFT PROLAPSE SYSTEM is a surgical mesh kit intended for transvaginal surgical treatment to correct anterior vaginal wall prolapse and posterior vaginal wall prolapse. The kit includes instrumentation for transvaginal placement.
Device Description
The Surelift Prolapse System is a surgical mesh kit intended for transvaginal surgical treatment to correct anterior vaginal wall prolapse and posterior vaginal wall prolapse. The kit includes instrumentation for transvaginal placement.
The kit is composed by a monofilament polypropylene mesh, two anchors with sutures to fix the mesh at the sacrospinose ligament, two anchoring handles to place the anchors and four passers to place the mesh through the obturator foramens.
The mesh has six fixation points (two posterior fixation points and four arms):
- Two posterior fixation points that are fixed to the sacrospinose ligaments.
- Two middle arms that are passed through the arcus tendineus.
- Two anterior arms that are passed through the anterior part of the obturator foramen.
When placing the mesh, these six fixation points can be adjusted by the surgeon to leave the mesh flat at the proper tension avoiding wrinkles.
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