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510(k) Data Aggregation
K Number
K192953Device Name
APTOS Threads Polypropylene Surgical Sutures
Manufacturer
APTOS, LLC.
Date Cleared
2020-08-27
(311 days)
Product Code
GAW
Regulation Number
878.5010Why did this record match?
Applicant Name (Manufacturer) :
APTOS, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The APTOS Threads - Polypropylene Surgical Sutures are indicated for general soft tissue approximation, excluding closure of the epidermis, where use of a non-absorbable suture is appropriate.
Device Description
APTOS Threads - Polypropylene Surgical Sutures are a dyed, nonabsorbable, sterile surgical strand of polypropylene in USP size 2-0. The base product is an isotactic crystalline stereoisomer of polypropylene, a synthetic linear polyolefin. The pigmented suture is dyed blue (with [Phthalocyaninato(2-)] copper, Color Index Number 74160) to enhance visibility; the colorant meets all requirements of US 21CFR, Parts 70-82. There is no coating or any other additives. The threads incorporate a bidirectional barbed design. The threads are supplied with needles attached to both ends. The thread's upper and lower anchoring sections are barbed in opposite direction with a small unbarbed section between them and two smooth unbarbed sections, each immediately adjacent to needle-thread attachment interfaces. The needles are constructed from 420B stainless steel. The needles are provided sterile via Ethylene Oxide sterilization.
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