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510(k) Data Aggregation
K Number
K230730Device Name
Apyx
Manufacturer
Escala Medical
Date Cleared
2023-07-25
(131 days)
Product Code
PBQ
Regulation Number
884.4530Why did this record match?
Product Code :
PBQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Apyx is intended for attaching sutures to ligaments of the pelvic floor.
Device Description
The Apyx device is indicated for anchoring sutures to ligaments of the pelvic floor. The device consists of an implantable nitinol anchor with 4 prongs configured with either non-absorbable or resorbable suture. The anchor-suture assembly is contained within a cartridge, wherein the anchor / suture assembly is deployed to the target site from the cartridge with an applicator. An optional use retriever may be used to remove the anchor in the event of sub-optimal placement of an Anchor during the index procedure. The Apyx also includes an optional securement element which may be used as a suture retention device to distribute suture tension over a larger tissue area and aid in wound healing.
The Apyx device is a single use device which is supplied sterile.
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K Number
K220420Device Name
Saffron Fixation System
Manufacturer
Coloplast A/S
Date Cleared
2022-06-10
(116 days)
Product Code
PBQ
Regulation Number
884.4530Why did this record match?
Product Code :
PBQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Saffron™ Fixation System is indicated for attaching suture to ligaments of the pelvic floor.
Device Description
The Saffron Fixation System consists of a single-use disposable Saffron Fixation Tool (delivery tool) and implantable tissue fixation Saffron Anchors (packaged and sold separately) made of polysulfone that are intended to be compatible with commercially available sutures up to size 0 (not provided as a part of the system). The delivery tool facilitates anchor placement with or without direct visualization and may be used to implant multiple anchors in a single patient as needed by the surgeon. The fixation anchors are multi-barbed hooks that provide permanent fixation points for suture attachment to the sacrospinous ligament.
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K Number
K213783Device Name
Apyx
Manufacturer
Escala Medical
Date Cleared
2022-04-05
(123 days)
Product Code
PBQ
Regulation Number
884.4530Why did this record match?
Product Code :
PBQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Apyx is intended for attaching sutures to ligaments of the pelvic floor.
Device Description
The Apyx device is indicated for anchoring sutures to ligaments of the pelvic floor. The device consists of an implantable nitinol anchor with 4 prongs configured with either non-absorbable or resorbable suture. The anchor-suture assembly is contained within a cartridge, wherein the anchor/suture assembly is deployed to the target site from the cartridge with an applicator. An optional retriever can be used to remove the anchor in the event of sub-optimal placement of an Anchor during the index procedure. The Apyx device is a single use device which is supplied sterile.
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K Number
K160569Device Name
NeuGuide
Manufacturer
POP Medical Solutions
Date Cleared
2016-07-06
(128 days)
Product Code
PBQ
Regulation Number
884.4530Why did this record match?
Product Code :
PBQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
NeuGuide is indicated for attaching sutures to ligaments of the pelvic floor.
Device Description
The NeuGuide™ device is indicated for anchoring sutures to ligaments of the pelvic floor. It is a single use instrument, supplied sterile and pre-loaded. The NeuGuide device comprises three elements, the anchor-suture unit, an applicator, and a thimble with work channel.
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K Number
K130059Device Name
ENDOFAST RELIANT SCP, ENDOFAST RELIANT LAP
Manufacturer
IBI ISRAEL BIOMEDICAL INNOVATIONS LTD.
Date Cleared
2013-07-29
(200 days)
Product Code
PBQ, OTO
Regulation Number
884.4530Why did this record match?
Product Code :
PBQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EndoFast Reliant™ SCP is indicated for fixation of surgical mesh to tissue for tissue reinforcement during a laparoscopic Sacrocolpopexy approach.
The EndoFast Reliant™ LAP is indicated for fixation of surgical prosthetic material to tissues for tissue reinforcement during a laparoscopic Sacrocolpopexy approach.
Device Description
The EndoFast Reliant™ SCP (Sacrocolpopexy) is a sterile, single use system which consists of the following parts:
- 3 metal Fixation Devices; each preloaded with a spider fastener composed of . metal and includes the MRI Safety Information that is stated in the labeling.
- . Plastic Handle; connects to the Fixation Device.
- . Surgical mesh composed of monofilament polypropylene material; cut in a rectangular shape of 8x20cm.
The device is introduced through a 5mm trocar in a laparoscopic approach. The mesh is attached to the vaginal vault and the vagina is pulled towards the posterior pelvic bony part. The other end of the mesh is attached to the promontorium, using two fixation points, to restore the normal anatomical position of the uterus and cervix.
The EndoFast Reliant™ LAP (Laparoscopic) is a sterile, single use system which consists of the following parts:
- 3 metal Fixation Devices, each preloaded with a spider fastener composed of . metal and include the MRI Safety Information that is stated in the labeling.
- Plastic Handle; connects to the Fixation Device. .
The fasteners are introduced through a 5mm trocar in laparoscopic procedures.
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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?
Product Code :
PBQ
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
K042603Device Name
GYNECARE PROLENE FASTENER SYSTEM
Manufacturer
ETHICON, INC.
Date Cleared
2004-12-22
(89 days)
Product Code
PBQ
Regulation Number
884.4530Why did this record match?
Product Code :
PBQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The GYNECARE PROLENE Fastener System is indicated for the attachment of knitted, nonwoven surgical mesh and suture to ligaments of the pelvic floor.
Device Description
The GYNECARE PROLENE Fastener consists of the implantable nonabsorbable PROLENE polypropylene Fastener.
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