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Found 15 results
510(k) Data Aggregation
K Number
K142656Device Name
Surgical Gut Suture
Manufacturer
COVIDIEN
Date Cleared
2015-01-29
(133 days)
Product Code
GAL
Regulation Number
878.4830Why did this record match?
Product Code :
GAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Plain, Chromic and Mild Chromic gut absorbable sutures are in general soft tissue approximation and/or ligation, including use in ophthalmic surgery, but not for use in microsurgery, cardiovascular or neurological surgery.
Device Description
Covidien's surgical gut sutures are absorbable sterile surgical sutures composed of purified connective tissue (mostly collagen) derived from the serosal layer of bovine intestines. They are packaged in a solution of 87% isopropanol, 12% water and 1% triethanolamine.
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K Number
K072930Device Name
DEMETECH ABSORBABLE SURGICAL SUTURE PLAIN & CHROMIC GUT
Manufacturer
DEMETECH CORP.
Date Cleared
2008-04-30
(197 days)
Product Code
GAL
Regulation Number
878.4830Why did this record match?
Product Code :
GAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Demetech Absorbable Surgical Gut Suture (Plain and Chromic) is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures".
Device Description
Demetech Surgical gut suture (Plain and Chromic) is an absorbable sterile surgical suture composed of purified connective tissue (mostly collagen) derived from either the serosal layer of beef (bovine) or the submucosal fibrous layer of sheep (ovine) intestines.
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K Number
K042287Device Name
UNIPLAIN & UNICHROM
Manufacturer
UNITED MEDICAL INDUSTRIES CO. LTD.
Date Cleared
2005-09-07
(379 days)
Product Code
GAL
Regulation Number
878.4830Why did this record match?
Product Code :
GAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
UniPlain & UniChrom are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular procedures and neurological procedures.
Device Description
Not Found
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K Number
K042897Device Name
AUTOBAHN TISSUE CLOSURE DEVICE AND DISPOSABLE CARTRIDGE
Manufacturer
ETHICON ENDO-SURGERY, INC.
Date Cleared
2004-11-19
(30 days)
Product Code
GAL, GAM, GAP, GAQ, GDF, NBY, NJU
Regulation Number
878.4830Why did this record match?
Product Code :
GAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AUTOBAHN Tissue Closure Device and Disposable Cartridge is intended for soft tissue approximation and/ or ligation in general surgical procedures.
Device Description
The AUTOBAHN Tissue Closure Device is a non-sterile, reusable device for use with the AUTOBAHN Disposable Cartridge. The AUTOBAHN Disposable Cartridge is a sterile; single-use disposable cartridge containing a standard type needle and standard, absorbable and non-absorbable, suture that is attached to the reusable AUTOBAHN Tissue Closure Device. The AUTOAHN Tissue Closure Device and Disposable Cartridge are indicated for soft tissue approximation and/ or ligation in general surgical procedures. The needle is contained within the AUTOBAHN Disposable Cartridge before, during, and after the case, aiding in the prevention of suture needle sticks to the surgeons, nurses, and OR staff. The AUTOBAHN tissue Closure Device needle is driven around inside the cartridge in a complete 360° arc. A completed stitch is placed each time the needle and suture are driven across the aperture and through tissue located within the aperture.
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K Number
K030227Device Name
SUTURTEK FASTCLOSE SUTURING DEVICE
Manufacturer
SUTURTEK INCORPORATED
Date Cleared
2003-03-17
(54 days)
Product Code
GAL
Regulation Number
878.4830Why did this record match?
Product Code :
GAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SuturTek FASTCLOSE Suturing Device is intended for soft tissue approximation and/or ligation in general surgical procedures.
The use of this device with absorbable sutures is not indicated for use in cardiovascular and neurological procedures.
It is designed to aid in the prevention of suture needle stick injuries.
Device Description
The FASTCLOSE Device has four major components: 1) a reusable instrument, 2) a single-use, disposable cartridge, 3) a single-use, disposable needle, and 4) sutures.
The cartridge containing the needle (with suture attached) is loaded onto the distal end of the device. The needle is engaged by the device's internal drive mechanism and driven through the tissue to be sutured. The suture is thus passed completely through the wound. Once the suture is in place, the device is withdrawn from the incision leaving the suture strand looped through the tissue. The two ends of the suture are then tied together in the usual manner.
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K Number
K020597Device Name
SERRALGUT
Manufacturer
SERRAL, S.A. DE C.V.
Date Cleared
2002-08-14
(173 days)
Product Code
GAL
Regulation Number
878.4830Why did this record match?
Product Code :
GAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SERRALGUT™ sutures are indicated for use in general soft tissue approximation and/or ophthalmic procedures, but not for use in cardiovascular and neurological procedures.
Device Description
Not Found
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K Number
K021043Device Name
GRAMS ABSORBABLE SURGICAL GUT SUTURE PLAIN & CHROMIC
Manufacturer
GRAMSMED LLC
Date Cleared
2002-06-21
(81 days)
Product Code
GAL
Regulation Number
878.4830Why did this record match?
Product Code :
GAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Grams Absorbable Surgical Gut Suture (Plain and Chromic) is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures.
Device Description
Grams Surgical gut suture (Plain and Chromic) is an absorbable sterile surgical suture composed of purified connective tissue (mostly collagen) derived from either the serosal layer of beef (bovine) or the submucosal fibrous layer of sheep (ovine) intestines.
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K Number
K011105Device Name
SUTURTEK FASTCLOSE FASCIA CLOSURE DEVICE
Manufacturer
QRC CONSULTING
Date Cleared
2001-05-30
(49 days)
Product Code
GAL, GAB, HCF
Regulation Number
878.4830Why did this record match?
Product Code :
GAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K001299Device Name
PLAIN AND CHROMIC GUT ABSORBABLE SURGICAL SUTURES USP
Manufacturer
CP MEDICAL
Date Cleared
2000-06-23
(60 days)
Product Code
GAL
Regulation Number
878.4830Why did this record match?
Product Code :
GAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K000542Device Name
PLAIN AND CHRONIC GUT ABSORBABLE SURGICAL SUTURES, USP
Manufacturer
ARC MEDICAL SUPPLIES (BEIJING) CO, LTD.
Date Cleared
2000-04-28
(71 days)
Product Code
GAL
Regulation Number
878.4830Why did this record match?
Product Code :
GAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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