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510(k) Data Aggregation
K Number
K250977Device Name
Suture-TOOL System
Manufacturer
Suturion AB
Date Cleared
2025-04-28
(28 days)
Product Code
NEW, GAB
Regulation Number
878.4840Why did this record match?
Applicant Name (Manufacturer) :
Suturion AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Suture-TOOL System is intended for abdominal wall closure after laparotomy in patients 18 years old and older.
Device Description
The Suture-TOOL System is a single-use, sterile, suture applicator with a polydioxanone resorbable suture pre-mounted to the needle. The polydioxanone monofilament synthetic absorbable sutures are prepared from polyester, poly(p-dioxanone). The empirical molecular formula of the polymer is as follows: -(O-CH2-CH2-O-CH2-CO)n- The sutures are dyed with D&C Violet No. 2 (21CFR§ 74.3602). The Suture-TOOL System includes the following: • Polydioxanone resorbable suture pre-mounted on the needle – 1055S, 1020S (Suture&Needle). • Suture-TOOL – 1018S (suture applicator). Before use, the user must follow the instructions to attach the needle, preloaded with the suture, to the applicator.
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K Number
K242835Device Name
Suture-TOOL System
Manufacturer
Suturion AB
Date Cleared
2025-01-22
(125 days)
Product Code
NEW
Regulation Number
878.4840Why did this record match?
Applicant Name (Manufacturer) :
Suturion AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Suture-TOOL System is intended for abdominal wall closure after laparotomy in patients 18 years old and older.
Device Description
The Suture-TOOL System is a single-use, sterile, suture applicator with a polydioxanone resorbable suture pre-mounted to the needle. The polydioxanone monofilament synthetic absorbable sutures are prepared from polyester, poly(p-dioxanone). The empirical molecular formula of the polymer is as follows: -(0-CH2-CH2-O-CH2-CO)n- The sutures are dyed with D&C Violet No. 2 (21CFR§ 74.3602) and are available in size 2. The Suture-TOOL System includes the following: - Polydioxanone resorbable suture pre-mounted on the needle -1020S (Suture&Needle). - Suture-TOOL 1018S (suture applicator) Before use, the user must follow the instructions to attach the needle, preloaded with the suture, to the applicator.
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