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510(k) Data Aggregation
K Number
K191268Device Name
Force Fiber Suture
Manufacturer
Teleflex Medical Incorporated
Date Cleared
2019-06-11
(29 days)
Product Code
GAT
Regulation Number
878.5000Why did this record match?
Applicant Name (Manufacturer) :
Teleflex Medical Incorporated
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Force Fiber® Non-absorbable Surgical Sutures are indicated for use in approximation and/or ligation of soft tissues, including use in cardiovascular surgeries and the use of allograft tissue for orthopedic surgeries.
Device Description
Force Fiber Suture - Black is a non-absorbable, sterile, surgical suture composed of Ultra High Molecular Weight Polyethylene (UHMWPE) dyed black using D&C Black #4 not to exceed 1.0% by weight. It is an uncoated braid offered in a variety of cut lengths, with or without needles, and provided sterile for single use only. Force Fiber Suture - Black is available in sizes 0, 1 and 2, and meets all surgical suture requirements established by the USP for non-absorbable surgical sutures except for oversize diameter.
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K Number
K181774Device Name
Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures; Force Fiber OrthoTape suture; Bondek suture and Bondek Plus suture; Monodek suture; Polyglytone*6211 suture
Manufacturer
Teleflex Medical Incorporated
Date Cleared
2018-10-10
(99 days)
Product Code
GAT, GAM, NEW
Regulation Number
878.5000Why did this record match?
Applicant Name (Manufacturer) :
Teleflex Medical Incorporated
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Force Fiber® Non-absorbable Surgical Sutures are indicated for use in approximation and/or ligation of soft tissues, including use in cardiovascular surgeries and the use of allograft tissue for orthopedic surgeries.
Force Fiber®OrthoTape® Suture is indicated for use in approximation and/or ligation of soft tissues, including use of allograft tissue for orthopedic surgeries.
Bondek® and Bondek® Plus Synthetic Absorbable Surgical Sutures are intended for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in and neurological procedures.
Monodek Monofilament Synthetic Absorbable Surgical Sutures are indicated for use in all types of soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery. Monodek® suture is not indicated in adult cardiovascular tissue, microsurgery and neural tissue. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to six weeks) is desirable.
Polyglytone*6211™ Monofilament Synthetic Absorbable Surgical Sutures are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular surgery, neurological surgery, or microsurgery.
Device Description
Force Fiber Suture is a non-absorbable, sterile, surgical suture composed of Ultra High Molecular Weight Polyethylene (UHMWPE). It is available as braided undyed (white), braided blue, co-braid of white UHMWPE and blue polypropylene (PP) monofilament strands, co-braid of white UHMWPE fibers and black Nylon monofilament strands, and co-braid of white UHMWPE fibers and green polyester (PET) fibers.
Force Fiber OthoTape Suture is an uncoated braid that is flat in shape and differs from USP requirements (not USP). It is available in 1mm, 1.5mm, 2.5mm, 3.5mm, 4mm and 5mm tape sizes and composed of undyed or blue Ultra High Molecular Weight Polyethylene (UHMWPE), or UHMWPE/ Green Polyester co-braid.
Bondek and Bondek Plus Suture is an absorbable, braided multifilament suture composed of a homopolymer of glycolic acid, polyglycolic acid. The Bondek suture material is coated with polycaprolactone-glycerol monostearate solution, and is available in green and beige (undyed) USP sizes 8-0 through 2. The Bondek Plus suture material is coated with polycaprolactone-co-polygolycolic acid, and is available in violet, green or beige (undyed) USP sized 6-0 through2.
Monodek Absorbable Surgical Suture is a monofilament suture that meets all USP requirements except for oversize diameter. Monodek is available in sizes 6-0 through 0 (metric sizes 0.7 through 3.5), undyed and dyed (violet). The suture may be supplied on ligating reels.
Polyglytone* 6211 suture, U.S.P size 2-0, is available, undyed (natural). The suture is monofilament, and may be provided with or without plegets.
The Teleflex surgical sutures are provided sterile (EO), for singe use only and may be provided in a variety of cut lengths with or without needles. A variety of attached needles are available from either 300 or 400 series stainless steel.
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K Number
K172016Device Name
Force Fiber Fusion Suture
Manufacturer
Teleflex Medical Incorporated
Date Cleared
2017-10-03
(92 days)
Product Code
GAT
Regulation Number
878.5000Why did this record match?
Applicant Name (Manufacturer) :
Teleflex Medical Incorporated
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Force Fiber Fusion™ Suture is indicated for use in approximation and/or ligation of soft tissues, including use of allograft tissue for orthopaedic surgeries.
Device Description
Force Fiber Fusion suture is an uncoated braid offered in a variety of cut lengths, with or without needles, and provided sterile for single use only. Force Fiber Fusion Suture is braided to transition from round suture to tape suture and back to round suture within the same braid construction. The tape section(s) are flat in shape and differ from USP requirements. The round section(s) exceed USP for diameter. The suture meets USP tensile strength requirements and USP needle attachment requirements. Force Fiber Fusion suture is available in sizes 1 through 5 and composed of undyed or blue Ultra High Molecular Weight Polyethylene (UHMWPE), UHMWPE/blue polyester co-braid, UHMWPE/black Nylon co-braid or UHMWPE/green Polyester co-braid.
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