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510(k) Data Aggregation
K Number
K150032Device Name
GluStitch Twist Tissue Adhesive
Manufacturer
Date Cleared
2016-01-14
(371 days)
Product Code
Regulation Number
878.4010Why did this record match?
Applicant Name (Manufacturer) :
GLUSTITCH, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
GluStitch® Twist Tissue Adhesive is intended for the topical skin incisions and trauma-induced lacerations in areas of low skin tension that are simple, thoroughly-cleansed, and have easily approximated skin edges. GluStitch® Twist may be used in conjunction with, but not in place of, deep dermal stitches.
Device Description
GluStitch Twist Tissue Adhesive is a sterile, topical tissue adhesive containing n-butyl-2-cyanoacrylate. GluStitch Twist Tissue Adhesive is supplied in a single patient use, twist-and-use ampoule that contains at least 0.5g of liquid tissue adhesive.
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K Number
K083752Device Name
GLUSEAL 90, MODEL GLU9010
Manufacturer
Date Cleared
2009-02-23
(68 days)
Product Code
Regulation Number
880.5090Why did this record match?
Applicant Name (Manufacturer) :
GLUSTITCH, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
GluSeal® 90 liquid adhesive bandage is intended to cover minor cuts, scrapes, burns, and minor irritations of the skin and help protect them from infection.
Device Description
The GluSeal® 90 is a formulated compound of the cyanoacrylate series. The compound, which exists in monomeric form in the plastic containers, polymerizes extremely rapidly in the presence of anions, especially of hydroxyl ions [in the presence of water]. It has the ability to adhere to moist living tissues. It demonstrates a favorable tissue response and reveals no toxic or foreign body reaction in humans.
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K Number
K071484Device Name
PERIACRYL 90,80,70,60, MODEL9010, 8020, 7030, 6040
Manufacturer
Date Cleared
2007-10-10
(133 days)
Product Code
Regulation Number
872.3275Why did this record match?
Applicant Name (Manufacturer) :
GLUSTITCH, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
PeriAcryl® 90, PeriAcry18 80, PeriAcry1 70, and PeriAcry16 60 are indicated to be used as an adjunct to temporarily assist in securing periodontal dressings.
Device Description
The Family of PeriAcryl® is a formulated compound of the cyanoacrylate series. It is available in 90/10 butyl/octyl, 80/20, butyl/octyl, 70/30 butyl/octyl and 60/40 butyl/octyl formulations depending on the dentist's preference. The compound, which exists in monomeric form in the plastic containers, polymerizes extremely rapidly in the presence of anions, especially of hydroxyl ions [in the presence of water]. It has the ability to adhere to moist living tissues. It demonstrates a favorable tissue response and reveals no toxic or foreign body reaction in humans.
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K Number
K030574Device Name
GLUSEAL 5ML DISPENSER, 1 ML DISPENSER, .2 ML DISPENSER
Manufacturer
Date Cleared
2003-08-21
(178 days)
Product Code
Regulation Number
880.5090Why did this record match?
Applicant Name (Manufacturer) :
GLUSTITCH, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
GluSeal™ liquid adhesive bandage is intended to cover minor cuts, scrapes, burns, and minor irritations of the skin and help protect them from infection.
Device Description
GluSeal™ is monomeric 2 octyl cyanoacrylate. This compound, which exists in monomeric form in the plastic containers, polymerizes extremely rapidly in the presence of anions, especially of hydroxyl ions (in the presence of water).
GluSeal™ will be packaged in three different ways ranging from a multiuse bottle containing 5 ml cyanoacrylate; a multiuse vial containing 1 ml cyanoacrylate, and a kit containing 12 x 0.2 ml disposable applicators. Each of the multiuse kits will contain application pipettes and administration dishes or administration trays.
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K Number
K013446Device Name
GLUSITE, MODEL GLU002
Manufacturer
Date Cleared
2001-12-20
(64 days)
Product Code
Regulation Number
872.3275Why did this record match?
Applicant Name (Manufacturer) :
GLUSTITCH, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
GluSite is indicated for use as dental cement for bonding dental materials such as crowns, caps, and pins, or temporarily attaching a fiber to the surface of the tooth in a procedure to treat periodontal disease.
Device Description
GluSite (2-octyl cynoacrylate) is a clear colorless, free-flowing liquid monomer packaged in a glass multiple-use vials. Upon contact with weak bases, GluSite polymerizes to form a strong adhesive bond. Depending on the availability of moisture, this could take up to one minute.
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