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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 a medical device manufactured by Lsi Solutions. It received FDA 510(k) clearance on 2017-06-02 under approval 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. It is manufactured by Lsi Solutions. The 510(k) number is K163639.

When was LS-5 ePTFE Suture approved by the FDA?

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

What company makes LS-5 ePTFE Suture?

LS-5 ePTFE Suture is manufactured by Lsi Solutions.

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

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

Other Devices by Lsi Solutions

K203081RAM COR-SUTURE QUCIK LOAD Surgical Suture, COR-SUTURE QUICK LOAD Surgical Suture

Related Devices (Code: NBY)

K160744LOOK PTFE SutureSurgical Specialties Corporation K170842WEGO-PTFEFoosin Medical Supplies Inc., Ltd. K163049GOLNIT Non-Absorbable PTFE Surgical SutureAntarma Dba Golnit Sutures K181578DemeTECH PTFE Nonabsorbable Surgical SutureDemetech Corporation K180630PTFE SURGICAL SUTUREOmnia Spa K173922C-PTFETM Surgical SutureCp Medical, Inc.

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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