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Found 29 results
510(k) Data Aggregation
K Number
K141625Device Name
POLYSYN SURGICAL SUTURE
Manufacturer
SURGICAL SPECIALTIES CORP.
Date Cleared
2014-07-18
(31 days)
Product Code
GAM
Regulation Number
878.4493Why did this record match?
Applicant Name (Manufacturer) :
SURGICAL SPECIALTIES CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
POLYS YN™ Polyglycolic Acid (PGA) Suture 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
PGA Sutures are supplied as braided or monofilament, dyed (violet) or undyed and coated or uncoated. The pigment for the violet is D&C Violet #2. Where applicable, the coating is a copolymer of polycarpolactone and calcium stearate. The PGA Suture is available in Size 2 through Size 10-0.
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K Number
K141558Device Name
QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE
Manufacturer
SURGICAL SPECIALTIES CORP.
Date Cleared
2014-07-11
(29 days)
Product Code
GAM
Regulation Number
878.4493Why did this record match?
Applicant Name (Manufacturer) :
SURGICAL SPECIALTIES CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Quill™ MONODERM™ device is indicated for use in soft tissue approximation where the use of absorbable sutures is appropriate.
Device Description
The Quill™ Monoderm™ Knotless Tissue-Closure Device is a sterile, synthetic absorbable tissue approximation device that is comprised of a copolymer of glycolide and e-caprolactone, undyed, or dyed with D&C Violet No. 2. The device is designed with small bi-directional barbs along the long axis of the suture monofilament. It is available in diameter Sizes 0 to 5-0, in various lengths affixed to various needle types.
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K Number
K140227Device Name
MONODERM SURGICAL SUTURE
Manufacturer
SURGICAL SPECIALTIES CORP.
Date Cleared
2014-02-28
(29 days)
Product Code
GAM
Regulation Number
878.4493Why did this record match?
Applicant Name (Manufacturer) :
SURGICAL SPECIALTIES CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
MONODERM™ (PGA-PCL) suare is indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.
Device Description
Monoderm™ (PGA-PCL) suture is a monofilament synthetic absorbable surgical suture prepared from a copolymer of glycolide and e-carpolactone. The Monoderm™ (PGA-PCL) suture is available dyed and undyed in Size 1 through Size 6-0.
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K Number
K133420Device Name
TRANQUILL BARBED DEVICE
Manufacturer
SURGICAL SPECIALTIES CORP. DBA ANGIOTECH
Date Cleared
2013-11-29
(21 days)
Product Code
NEW
Regulation Number
878.4840Why did this record match?
Applicant Name (Manufacturer) :
SURGICAL SPECIALTIES CORP. DBA ANGIOTECH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The TranQuill barbed device comprised of polydioxanone, is indicated for soft tissue approximation where use of an absorbable suture is appropriate.
Device Description
The TranQuill barbed device is a sterile, synthetic absorbable device that is intended for use in the approximation of soft tissue. It is comprised of polyester [poly (p-dioxanone)], dyed with D&C Violet No. 2. The device is designed with small bi-directional barbs along the long axis of the suture monofilament. It is available in diameter Size 0 through 2-0 in various lengths affixed to various needle types.
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K Number
K131224Device Name
SHARPOINT POLYPROPYLENE SURGICAL SUTURE, LOOK POLYPROPYLENE SURGICAL SUTURE, QUILL POLYPROPYLENE KNOTLESS TISSUE-CLOSURE
Manufacturer
SURGICAL SPECIALTIES CORP. DBA ANGIOTECH
Date Cleared
2013-05-16
(16 days)
Product Code
GAW
Regulation Number
878.5010Why did this record match?
Applicant Name (Manufacturer) :
SURGICAL SPECIALTIES CORP. DBA ANGIOTECH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Polypropylene suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
Quill™ Knotless Tissue-Closure Device comprised of Polypropylene is indicated for soft tissue approximation excluding closure of the epidermis.
Device Description
The Polypropylene Surgical Suture and Quill™ Polypropylene Tissue-Closure Devices are sterile, synthetic Knotless nonabsorbable surgical suturing devices that are intended for use in the closure of soft tissue. They are comprised of high molecular weight, isotactic polypropylene, undyed, or dyed with Phthalocyaninato (2-) Copper. The proposed blue modification is a change in supplier of the polypropylene resin raw material. The devices are supplied either single or doublearmed with various needle types, and are available in USP diameter Sizes 2 through 11-0, as applicable.
The Quill™ Polypropylene devices are designed with either small opposing bi-directional or uni-directional barbs along the long axis of the suture monofilament. The uni-directional products contain a welded primary loop and secondary loop design at the distal end, opposite the attached needle.
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K Number
K130078Device Name
QUILL POLYPROPYLENE KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN
Manufacturer
SURGICAL SPECIALTIES CORP. DBA ANGIOTECH
Date Cleared
2013-02-28
(45 days)
Product Code
GAW
Regulation Number
878.5010Why did this record match?
Applicant Name (Manufacturer) :
SURGICAL SPECIALTIES CORP. DBA ANGIOTECH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Quill™ Knotless Tissue-Closure Device comprised of Polypropylene is indicated for soft tissue approximation excluding closure of the epidermis.
Device Description
The Quill™ Polypropylene Knotless Tissue-Closure Device, Variable Loop Design is a sterile, synthetic nonabsorbable tissue-closure device that is intended for use in the closure of soft tissue, excluding closure of the epidermis. It is comprised of high molecular weight, isotactic polypropylene, undyed, or dyed blue with Phthalocyaninato (2-) Copper. The device is designed with small uni-directional barbs along the long axis of the suture monofilament which contains a welded primary loop and secondary loop design at the distal end. It is available in diameter Size 0 in various lengths affixed to various needle types.
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K Number
K123877Device Name
QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN
Manufacturer
SURGICAL SPECIALTIES CORP. DBA ANGIOTECH
Date Cleared
2013-01-02
(16 days)
Product Code
NEW
Regulation Number
878.4840Why did this record match?
Applicant Name (Manufacturer) :
SURGICAL SPECIALTIES CORP. DBA ANGIOTECH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
QuillTM PDO Knotless Tissue-Closure Device comprised of Polydioxanone is indicated for soft tissue approximation where use of an absorbable suture is appropriate.
Device Description
The QuillTM PDO Knotless Tissue-Closure Device, Variable Loop Design (Polydioxanone) is a sterile, synthetic absorbable tissue- closure device that is intended for use in the closure of soft tissue. It is comprised of polyester [poly (p-dioxanone)], dyed with D&C Violet No. 2. The instrument is designed with small uni- directional barbs along the long axis of the suture monofilament which contains a welded primary loop and secondary loop design at the distal end. It is available in diameter Size 0, 2-0 and 3-0 in various lengths affixed to various needle types.
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K Number
K123836Device Name
QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN
Manufacturer
SURGICAL SPECIALTIES CORP. DBA ANGIOTECH
Date Cleared
2012-12-21
(8 days)
Product Code
GAM
Regulation Number
878.4493Why did this record match?
Applicant Name (Manufacturer) :
SURGICAL SPECIALTIES CORP. DBA ANGIOTECH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Quill™ Knotless Tissue-Closure Device comprised of Monoderm™ is indicated for soft tissue approximation where use of an absorbable suture is appropriate.
Device Description
The QuillTM MonodermTM Knotless Tissue-Closure Device, Variable Loop Design is a sterile, synthetic absorbable tissue-closure device that is intended for use in the closure of soft tissue. It is comprised of a copolymer of glycolide and e-caprolactone, undyed, or dyed with D&C Violet No. 2. The device is designed with small uni-directional barbs along the long axis of the suture monofilament which contains a welded primary loop and secondary loop design at the distal end. It is available in diameter Sizes 1 to 3-0, in various lengths affixed to various needle types.
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K Number
K123409Device Name
QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN
Manufacturer
SURGICAL SPECIALTIES CORP. DBA ANGIOTECH
Date Cleared
2012-11-20
(15 days)
Product Code
GAM
Regulation Number
878.4493Why did this record match?
Applicant Name (Manufacturer) :
SURGICAL SPECIALTIES CORP. DBA ANGIOTECH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Quill™ Knotless Tissue-Closure Device comprised of Monoderm™ is indicated for soft tissue approximation where use of an absorbable suture is appropriate.
Device Description
The Quill <sup>TM</sup> Monoderm <sup>TM</sup> Knotless Tissue-Closure Device, Variable Loop Design is a sterile, synthetic absorbable tissue-closure device that is intended for use in the closure of soft tissue. It is comprised of a copolymer of glycolide and e-caprolactone, undyed, or dyed with D&C Violet No. 2. The device is designed with small uni-directional barbs along the long axis of the suture monofilament which contains a welded primary loop and secondary loop design at the distal end. It is available in diameter Sizes 2-0 to 0 in various lengths affixed to various needle types.
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K Number
K122898Device Name
QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN
Manufacturer
SURGICAL SPECIALTIES CORP. DBA ANGIOTECH
Date Cleared
2012-10-22
(31 days)
Product Code
GAM
Regulation Number
878.4493Why did this record match?
Applicant Name (Manufacturer) :
SURGICAL SPECIALTIES CORP. DBA ANGIOTECH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Quill™ Knotless Tissue-Closure Device comprised of Monoderm™ is indicated for soft tissue approximation where use of an absorbable suture is appropriate.
Device Description
The Quill™ Monoderm™ Knotless Tissue-Closure Device, Variable Loop Design is a sterile, synthetic absorbable tissue-closure device that is intended for use in the closure of soft tissue. It is comprised of a copolymer of glycolide and e-caprolactone. undyed, or dyed with D&C Violet No. 2. The device is designed with small uni-directional barbs along the long axis of the suture monofilament which contains a welded primary loop and secondary loop design at the distal end. It is available in diameter Size 2-0 in various lengths affixed to various needle types.
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