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Found 10 results
510(k) Data Aggregation
K Number
K141007Device Name
DEMESTEEL (STAINLESS STEEL) NON-ABSORBABLE SUTURE
Manufacturer
DEMETECH CORP.
Date Cleared
2014-09-25
(160 days)
Product Code
GAQ
Regulation Number
878.4495Why did this record match?
Applicant Name (Manufacturer) :
DEMETECH CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
"DemeSTEEL" is a stainless steel suture composed of 316L stainless steel with or without needles attached, and is intended for use in abdominal wound closure, intestinal anastomosis, hernia repair, sternal closure and certain orthopedic procedures, including cerclage and tendon repair.
Device Description
Demetech's DemeSTEEL is a Monofilament and/or Multifilament Non-absorbable surgical suture composed of 316L Stainless Steel and supplied with and without needles affixed to the sutures. Demetech's DemeSTEEL Surgical Suture meets the requirements established by the United States Pharmacopeia (U.S.P.) for nonabsorbable surgical sutures. DemeSTEEL Stainless Steel sutures are composed of 316L stainless steel conforming to the FDA recognized ASTM Standard F138 Grade 2 "Stainless steel bar and wire for surgical implants".
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K Number
K123940Device Name
DEMEQUICKTM (RAPID ABSORBABLE) SYNTHETIC SURGICAL SUTURE
Manufacturer
DEMETECH CORP.
Date Cleared
2014-05-30
(526 days)
Product Code
GAM
Regulation Number
878.4493Why did this record match?
Applicant Name (Manufacturer) :
DEMETECH CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
DemeQUICK (Rapid Absorbable) Synthetic Surgical Suture is indicated for use in general soft tissue approximation (i.e., mucosa and skin) where only short term wound support (7-10 days) is required. DemeQUICK (Rapid Absorbable) Synthetic Surgical Suture is not intended for use in ligation, cardiovascular, ophthalmic or neurological procedures.
Device Description
DemeQUICK Absorbable suture is an absorbable sterile surgical suture composed of copolymers made from 90% alvcolide and 10% L-lactide. DemeQUICK Absorbable suture is coated with a copolymer made from 30% glycolide 70% L-lactide and calcium stearate, it is available un-dved from sizes: USP 6-0 to USP 2. The DemeQUICK Absorbable suture complies with the requirements established by the United States Pharmacopoeia (USP) for absorbable suture, with tensile strength meeting the collagen table.
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K Number
K130083Device Name
DEMECAPRONE (POLIGLECAPRONE 25) SYNTHETIC MONOFILAMENT (PGCL) ABSORBABLE SUTURE
Manufacturer
DEMETECH CORP.
Date Cleared
2013-07-17
(184 days)
Product Code
GAM
Regulation Number
878.4493Why did this record match?
Applicant Name (Manufacturer) :
DEMETECH CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Demetech Absorbable Poliglecaprone 25 Surgical Suture is indicated for use in general soft tissue approximation and/or ligation, but not for use cardiovascular surgery, microsurgery, ophthalmic surgery and neurological tissue.
Device Description
DemeCAPRONE (Poliglecaprone 25) is a synthetic monofilament absorbable surgical suture composed of Poly (glycolic-co-caprolactone) copolymer (PGCL) and is supplied un-dyed and dyed with D&C Violet #2 below 0.1wt%. DemeCAPRONE (Poliglecaprone 25) synthetic absorbable suture is available in sizes 6-0 through 1 (metric sizes 0.7 - 4). DemeCAPRONE (Poliglecaprone 25) Surgical Suture meets the requirements established by the United States Pharmacopeia (U.S.P.) for synthetic absorbable surgical sutures except for diameter.
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K Number
K082097Device Name
DEMETECH POLYDIOXANONE SYNTHETIC MONOFILAMENT (PDO) ABSORBABLE SUTURE
Manufacturer
DEMETECH CORP.
Date Cleared
2010-01-08
(533 days)
Product Code
NEW
Regulation Number
878.4840Why did this record match?
Applicant Name (Manufacturer) :
DEMETECH CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Demetech Absorbable Polydioxanone Surgical Suture is indicated for use in all types of soft . tissue approximation including pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery, but not for use in adult cardiovascular, microsurgery and neural tissue. These sutures are useful where absorbable suture with extended wound support (up to six weeks) is desirable.
Device Description
Demetech's Polydioxanone is a synthetic monofilament absorbable surgical suture composed of polyester polymers poly (p-dioxanone) and is supplied un-dyed violet with D & C violet #2. Demetech's Polydioxanone surgical sutures meet the requirements established by the United States Pharmacopeia (U.S.P.) for synthetic absorbable surgical sutures.
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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?
Applicant Name (Manufacturer) :
DEMETECH CORP.
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
K043330Device Name
POLYPROPILENE SURGICAL SUTURES
Manufacturer
DEMETECH CORP.
Date Cleared
2005-05-16
(165 days)
Product Code
GAW
Regulation Number
878.5010Why did this record match?
Applicant Name (Manufacturer) :
DEMETECH CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DemeTECH Polypropylene Surgical Suture is indicated for use in general soft tissue approximation and/or litigation including use in cardiovascular, ophthalmic, and neurological procedures.
Device Description
The DemeTECH polypropylene sutures are inert, non-absorbable, sterile surgical suture composed of an isotactic crystalline stereoisomer of polypropylene, a synthetic linear polylefin. The suture is pigmented to enhance visibility.
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K Number
K043539Device Name
DEMETECH STERILE SYNTHETIC ABSORBABLE SUTURES (PGA) AND NEEDLES
Manufacturer
DEMETECH CORP.
Date Cleared
2005-04-06
(105 days)
Product Code
GAM
Regulation Number
878.4493Why did this record match?
Applicant Name (Manufacturer) :
DEMETECH CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PGA Suture is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery, but not for use in cardiovascular or neurological tissue.
Device Description
Polyglycolic Acid (PGA) is a sterile absorbable synthetic, multifilament suture composed of glycolic acid. The yarns are braided and coated with a blend of polycaprolate, copolymer of caprolactone and glycolide. The PGA Suture is available in violet from sizes: USP8/0 USP2.
PGA fulfills all the requirements of USP and the European Pharmacopoeia for sterile, synthetic, absorbable sutures.
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K Number
K023028Device Name
DEMETECH NYLON NONABSORBABLE SUTURE
Manufacturer
DEMETECH CORP.
Date Cleared
2003-06-18
(280 days)
Product Code
GAR
Regulation Number
878.5020Why did this record match?
Applicant Name (Manufacturer) :
DEMETECH CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DemeTECH Nylon Nonabsorbable Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular and ophthalmic and neurological procedures.
Device Description
The DemeTECH Nylon Nonabsorbable Suture is a single use, individually packaged, disposable nonabsorbable nylon (polyamide) surgical suture.
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K Number
K023030Device Name
DEMETECH POLYESTER NONABSORBABLE SUTURE
Manufacturer
DEMETECH CORP.
Date Cleared
2003-06-18
(280 days)
Product Code
GAT
Regulation Number
878.5000Why did this record match?
Applicant Name (Manufacturer) :
DEMETECH CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DemeTECH Polyester Nonabsorbable Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular and ophthalmic and neurological procedures.
Device Description
The DemeTECH Polyester Nonabsorbable Suture is a braided green, individually packaged nonabsorbable Polyester surgical suture available in a range of gauge sizes and lengths, and attached to needles of varying types and sizes.
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K Number
K023029Device Name
DEMETECH SILK NONABSORBABLE SUTURE
Manufacturer
DEMETECH CORP.
Date Cleared
2002-11-25
(75 days)
Product Code
GAP
Regulation Number
878.5030Why did this record match?
Applicant Name (Manufacturer) :
DEMETECH CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DemeTECH Silk Nonabsorbable Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular and ophthalmic and neurological procedures.
Device Description
The DemeTECH Silk Nonabsorbable Suture is a black braided, individually packaged nonabsorbable silk surgical suture available in a range of gauge sizes and lengths, and attached to needles of varying types and sizes or supplied without needles.
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