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FDA 510(k)

LS-5 ePTFE Suture

K-Number: K163639 · 2017-06-02

ApplicantLsi Solutions
Decision Date2017-06-02
Product CodeNBY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LS-5 ePTFE Suture is the device name listed in this FDA 510(k) record. The listed applicant is Lsi Solutions. It received FDA 510(k) clearance on 2017-06-02 under 510(k) number K163639. The device is classified under product code NBY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LS-5 ePTFE Suture?

LS-5 ePTFE Suture is a medical device that received FDA 510(k) clearance on 2017-06-02. The listed applicant is Lsi Solutions. The 510(k) number is K163639.

When did LS-5 ePTFE Suture receive FDA 510(k) clearance?

LS-5 ePTFE Suture received FDA 510(k) clearance on 2017-06-02, under 510(k) number K163639.

Who is the listed applicant for LS-5 ePTFE Suture?

The FDA 510(k) record lists Lsi Solutions as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LS-5 ePTFE Suture?

The FDA product code for LS-5 ePTFE Suture is NBY.

Other records listing Lsi Solutions as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K222783MD Mattress Suture Placement DeviceK202551Cor-Knot MicroK203120RD QUICK LOAD SUTURE, 0 Polyester, RD QUICK LOAD SUTURE, 2-0 Polyester, RD QUCIK LOAD SUTURE, 2-0 PolypropyleneK203081RAM COR-SUTURE QUCIK LOAD Surgical Suture, COR-SUTURE QUICK LOAD Surgical Suture

Related Devices (Code: NBY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K231277TissueStatDurastat, LLCK192088GOLNIT Non-aborbable PTFE Surgical SutureAntarma, LLC Dba Golnit SuturesK180992BiotexPurgo Biologics, Inc.K191317StitchKitOrigami SurgicalK181578DemeTECH PTFE Nonabsorbable Surgical SutureDemetech CorporationK180630PTFE SURGICAL SUTUREOmnia Spa

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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