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Found 17 results
510(k) Data Aggregation
K Number
K083783Device Name
VF LIQUIGEL
Manufacturer
COAPT SYSTEMS, INC.
Date Cleared
2009-09-11
(266 days)
Product Code
MIX
Regulation Number
874.3620Why did this record match?
Applicant Name (Manufacturer) :
COAPT SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VF LiquiGel is indicated for vocal fold medialization in the treatment of vocal fold insufficiency, where insufficiency may be improved by injection of a soft tissue bulking agent. VF LiquiGel injection augments the size of the displaced or deformed vocal fold so that it may meet the opposing fold at the midline for improved glottal closure. Improved glottal closure may allow improved phonation, improvement of cough, and an improved ability to protect the airway during swallowing. VF LiquiGel is a temporary implant that degrades over time. The product is intended to be durable for a minimum of one month.
Device Description
Sterile, latex free, non-pyrogenic, highly thixotropic, high yield strength clear gel with a neutral pH. The durability of the gel is due to slow degradation of the synthetic gel carrier. The thixotropic character of the gel allows it to be a very thick and cohesive gel but able to be injected through very fine needles with minimal force.
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K Number
K080956Device Name
MODIFICATION TO VF GEL PLUS
Manufacturer
COAPT SYSTEMS, INC.
Date Cleared
2008-04-25
(22 days)
Product Code
MIX
Regulation Number
874.3620Why did this record match?
Applicant Name (Manufacturer) :
COAPT SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VF Gel is indicated for vocal fold medialization in the treatment of vocal fold insufficiency, where insufficiency may be improved by injection of a soft tissue bulking agent. VF Gel injection augments the size of the displaced or deformed vocal fold so that it may meet the opposing fold at the midline for improved glottal closure. Improved glottal closure may allow improved phonation, improvement of cough, and an improved ability to protect the airway during swallowing. VF Gel is a temporary implant that degrades over time. The product is intended to be durable for a minimum of one month.
Device Description
Sterile, latex free, non-pyrogenic, highly thixotropic, high yield strength clear gel with a neutral pH. The durability of the gel is due to slow degradation of the synthetic gel carrier. The thixotropic character of the gel allows it to be a very thick and cohesive gel but able to be injected through very fine needles with minimal force.
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K Number
K071663Device Name
VF GEL PLUS
Manufacturer
COAPT SYSTEMS, INC.
Date Cleared
2008-02-15
(242 days)
Product Code
MIX
Regulation Number
874.3620Why did this record match?
Applicant Name (Manufacturer) :
COAPT SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VF Gel Plus is indicated for vocal fold medialization in the treatment of vocal fold insufficiency, where insufficiency may be improved by injection of a soft tissue bulking agent. VF Gel Plus injection augments the size of the displaced or deformed vocal fold so that it may meet the opposing fold at the midline for improved glottal closure. Improved glottal closure may allow improved phonation, improvement of cough, and an improved ability to protect the airway during swallowing. VF Gel Plus is a temporary implant that degrades over time. The product is intended to be durable for a minimum of one month.
Device Description
Sterile, latex free, non-pyrogenic, semi-solid, cohesive subdermal implant. The principal durable component is synthetic calcium hydroxylapatite. The semi-solid nature is created by suspending the calcium hydroxylapatite particles in a high yield strength thixotropic gel. The isotonic gel carrier consists primarily of sterile water for injection (USP), glycerin (USP) and mannitol (USP). The thixotropic high yield strength gel is created by the carbomer (NF). The calcium hydroxylapatite particles are 25 to 45 microns in size while being smooth but irregular in shape and are present in the product at 30% by volume.
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K Number
K060248Device Name
ULTRATINE TRANSBLEPH
Manufacturer
COAPT SYSTEMS, INC.
Date Cleared
2006-06-12
(132 days)
Product Code
HWC
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
COAPT SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ULTRATINE TransBleph™ is intended for use in subperiosteal browplasty fixation. The ULTRATINE TransBleph is specifically indicated for use to fixate the subdermis to the frontal bone.
Device Description
The ULTRATINE TransBleph™ consists of a bioabsorbable implant. This device is supplied sterile for single use only.
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K Number
K060249Device Name
ULTRATINE FOREHEAD
Manufacturer
COAPT SYSTEMS, INC.
Date Cleared
2006-06-12
(132 days)
Product Code
HWC
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
COAPT SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ULTRATINE Forehead™ is intended for use in subperiosteal browplasty surgery. The ULTRATINE Forehead is specifically indicated for use to fixate the subdermis to the cranial bone in browplasty.
Device Description
The ULTRATINE Forehead™ consists of a bioabsorbable implant. This device is supplied sterile for single use only.
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K Number
K060828Device Name
MODIFICATION TO ENDOTINE RIBBON
Manufacturer
COAPT SYSTEMS, INC.
Date Cleared
2006-04-19
(23 days)
Product Code
GAM
Regulation Number
878.4493Why did this record match?
Applicant Name (Manufacturer) :
COAPT SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ENDOTINE Ribbon™ is indicated for use in elevation and fixation of tissues in the temporal region, midface, lower face/jowl to the deep temporal fascia and the neck to the mastoid fascia during cosmetic procedures.
Device Description
The ENDOTINE Ribbon™ consists of a bioabsorbable implant pre-loaded on an insertion tool. The device implant is a soft tissue fixation platform. The insertion tool and implant are sterilized together.
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K Number
K051415Device Name
ENDOTINE RIBBON
Manufacturer
COAPT SYSTEMS, INC.
Date Cleared
2005-06-23
(22 days)
Product Code
GAM
Regulation Number
878.4493Why did this record match?
Applicant Name (Manufacturer) :
COAPT SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ENDOTINE Ribbon™ is indicated for use in elevation and fixation of tissues in the temporal region, midface, lower face/jowl to the deep temporal fascia and the neck to the mastoid fascia during cosmetic procedures.
Device Description
The ENDOTINE Ribbon™ consists of an insertion tool/cover and a bioabsorbable implant. The device implant consists of fixation tines attached to an anchoring leash. This device along with its insertion tools are supplied sterile for single use only.
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K Number
K050611Device Name
ENDOTINE RIBBON
Manufacturer
COAPT SYSTEMS, INC.
Date Cleared
2005-04-06
(28 days)
Product Code
GAM
Regulation Number
878.4493Why did this record match?
Applicant Name (Manufacturer) :
COAPT SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ENDOTINE Ribbon™ is indicated for use in subperiosteal midface suspension surgery to fixate the cheek subdermis in an elevated position.
Device Description
The ENDOTINE Ribbon™ consists of a bioabsorbable implant pre-loaded on an insertion tool. The device implant is a soft tissue fixation platform. The insertion tool and implant are sterilized together.
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K Number
K042796Device Name
ENDOTINE TRANSBLEPH 3.0/3.5 DEVICE
Manufacturer
COAPT SYSTEMS, INC.
Date Cleared
2004-11-05
(29 days)
Product Code
HWC
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
COAPT SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ENDOTINE TransBleph™ is intended for use in subperiosteal browplasty. The ENDOTINE TransBleph™ is specifically indicated for use to fixate the subdermis to the frontal bone.
Device Description
The ENDOTINE TransBleph™ 3.0/3.5 Device consists of a bioabsorbable implant, an insertion tool, and stainless steel drill bit. The device implant is a soft tissue fixation platform that is anchored in the cranial bone. The insertion tool and the drill bit are sterilized together with the implant device in a plastic tray.
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K Number
K041835Device Name
ENDOTINE MIDFACE B 4.5 DEVICE
Manufacturer
COAPT SYSTEMS, INC.
Date Cleared
2004-09-28
(83 days)
Product Code
HWC, GAN
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
COAPT SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ENDOTINE Midface™ B 4.5 is intended for use in subperiosteal midface suspension surgery. Specifically, the ENDOTINE Midface™ B 4.5 is indicated for use in suspending the subcutaneous tissues of the midface from the infra-orbital rim or zygoma via an anchoring leash.
Device Description
The ENDOTINE Midface™-ST 4.5 consists of two components: (1) a fixation platform with anchoring leash, and (2) a screw anchor. This device is supplied sterile for single use only.
The ENDOTINE Midface™ B Instrument Kit is packaged separately from the implant device and is provided to the user non-sterile. The kit is comprised of the following tools that aid in the deployment and anchoring of the implant device:
- Sterilization tray (lid, base and mat) to house the instruments for transport and . sterilization
- Drill bit for creating a hole in the infra-orbital rim .
- Tapping tool to create the threads in the drilled hole to conform to the anchor . screw
- . Insertion tool to grasp and deploy the anchor screw
- Clipper tool to remove the screw flange and excess leash length .
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