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510(k) Data Aggregation
K Number
K171039Device Name
Assut Filbloc Permanent Sutures
Manufacturer
Assut Europe S.p.A.
Date Cleared
2017-08-29
(145 days)
Product Code
GAW
Regulation Number
878.5010Why did this record match?
Applicant Name (Manufacturer) :
Assut Europe S
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
FilBloc Permanent sutures are intended for general soft tissue approximation, excluding closure of the epidermis, where use of a non-absorbable suture is appropriate.
Device Description
The Assut FilBloc Permanent Suture range of devices comprises a variety of gauge sizes and lengths, supplied with or without stainless steel needles, which are also available in a variety of different sizes and shapes. The sutures may have a 'block' at one end, which allows surgeons to close wounds quickly and securely without tying knots or changing suturing techniques. The block is made from the same material as the suture, and is used to anchor the suture.
Assut FilBloc Permanent Sutures contact the patient and remain attached to the patient at the point suturing and may remain in place for significant periods.
The sutures with needles do not need to be used with any other devices, but the needleless sutures need to be used together with legally available separate needles.
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K Number
K150553Device Name
Filbloc
Manufacturer
ASSUT EUROPE
Date Cleared
2016-05-19
(442 days)
Product Code
NEW
Regulation Number
878.4840Why did this record match?
Applicant Name (Manufacturer) :
ASSUT EUROPE
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Filbloc sutures are indicated for use in general soft tissue approximation where use of an absorbable suture is appropriate.
Device Description
Filbloc (polydioxanone) monofilament synthetic absorbable sutures are prepared from the polyester, poly(p-dioxanone). The empirical molecular formula of the polymer is: -(0-CH2-CH2-O-CH2-CO-CH2-CO)n- Filbloc sutures are undyed or dyed with D&C Violet No. 2 (21CFR§ 74.3602). The device is designed with unidirectional or bidirectional barbs, or with unidirectional barbs and final block in PDO. The barbs and the block design allow for tissue approximation, without need to tie surgical knot. The device is available in various lengths and diameter sizes 2 through 4/0 with various needles attached at one end or to both ends.
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K Number
K021767Device Name
ASSUFIL
Manufacturer
ASSUT EUROPE S.P.A.
Date Cleared
2002-11-19
(174 days)
Product Code
GAM
Regulation Number
878.4493Why did this record match?
Applicant Name (Manufacturer) :
ASSUT EUROPE S
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Assufil It is advised when an absorbable suture is needed for use in General Soft Tissue Approximation and Ligation
Device Description
absorbable surgical suture
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