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510(k) Data Aggregation

    K Number
    K014183
    Device Name
    AFB (ABSORBABLE FOAM BUTTRESS)
    Manufacturer
    J&J CORPORATE BIOMATERIALS CENTER
    Date Cleared
    2002-06-12

    (174 days)

    Product Code
    FTL
    Regulation Number
    878.3300
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K921895,K923657,K940205,K942583,K971048,K992537,K955364,K001789,K915835,K960653,K964072
    Why did this record match?
    Device Name :

    AFB (ABSORBABLE FOAM BUTTRESS)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    AFB is indicated for use in surgical procedures in which soft tissue transection or resection with staple line reinforcement is needed.

    Device Description

    The AFB (Absorbable Foam Buttress) Reload is a sterile, single patient use device which consists of two components: a cartridge and an anvil carrier. A strip of buttressing material is attached to both the cartridge and anvil carrier. AFB reinforces the staple line in soft tissue while it is simultaneously being cut and stapled. AFB is prepared from a synthetic, bioabsorbable copolymer similar to that used in synthetic absorbable sutures.

    The AFB is integrated into endoscopic and open linear cutting/transecting staplers and reload cartridges. The two product reload cartridge configurations are suitable for the Endopath™ Endoscopic Linear Cutter used for VATS cases and the Linear Cutter used for OPEN cases.

    AI/ML Overview

    This document is a 510(k) summary for the AFB (Absorbable Foam Buttress) Reload device. It describes the device, its intended use, and its substantial equivalence to predicate devices, but it does not contain acceptance criteria or a study that evaluates device performance against such criteria.

    The document primarily focuses on:

    • Device Description: What the AFB Reload is and how it functions.
    • Predicate Devices: Listing similar devices already on the market to establish substantial equivalence.
    • Non-Clinical and Pre-Clinical Testing: General statements about testing performed (polymer composition, viscosity, thickness, tensile strength, toxicology, biocompatibility, absorbability), but no specific performance metrics or acceptance criteria are provided.
    • FDA Clearance: The letter from the FDA indicating clearance based on substantial equivalence.

    Therefore, I cannot provide the requested information because the provided text does not include acceptance criteria or the details of a study that proves the device meets specific performance criteria. The 510(k) clearance process relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against predefined acceptance criteria through an explicit study reported in this summary.

    To answer your request, a document detailing specific performance studies with acceptance criteria would be needed.

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