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FDA 510(k)

Pledgeted COR-SUTURE QUICK LOAD

K-Number: K160529 · 2016-09-15

ApplicantLsi Soultions
Decision Date2016-09-15
Product CodeGAW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Pledgeted COR-SUTURE QUICK LOAD is the device name listed in this FDA 510(k) record. The listed applicant is Lsi Soultions. It received FDA 510(k) clearance on 2016-09-15 under 510(k) number K160529. The device is classified under product code GAW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Pledgeted COR-SUTURE QUICK LOAD?

Pledgeted COR-SUTURE QUICK LOAD is a medical device that received FDA 510(k) clearance on 2016-09-15. The listed applicant is Lsi Soultions. The 510(k) number is K160529.

When did Pledgeted COR-SUTURE QUICK LOAD receive FDA 510(k) clearance?

Pledgeted COR-SUTURE QUICK LOAD received FDA 510(k) clearance on 2016-09-15, under 510(k) number K160529.

Who is the listed applicant for Pledgeted COR-SUTURE QUICK LOAD?

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

What is the FDA product code for Pledgeted COR-SUTURE QUICK LOAD?

The FDA product code for Pledgeted COR-SUTURE QUICK LOAD is GAW.

Related Devices (Code: GAW)

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.

K253572STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device STRATAFIX™ Spiral PRONOVA™ Bidirectional Knotless Tissue Control DeviceETHICON, Inc.K233355Cypris eXact Suturing SystemCypris MedicalK230746Non absorbable Surgical Polypropylene SutureShandong Haidike Medical Products Co., Ltd.K221280VessealLydus Medical , Ltd.K211178DURAMESH Mesh SutureMsiK192953APTOS Threads – Polypropylene Surgical SuturesAptos, LLC

Official Source

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

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