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FDA 510(k)

WEGO-PTFE

K-Number: K170842 · 2017-07-31

ApplicantFoosin Medical Supplies Inc., Ltd.
Decision Date2017-07-31
Product CodeNBY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

WEGO-PTFE is the device name listed in this FDA 510(k) record. The listed applicant is Foosin Medical Supplies Inc., Ltd.. It received FDA 510(k) clearance on 2017-07-31 under 510(k) number K170842. 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 WEGO-PTFE?

WEGO-PTFE is a medical device that received FDA 510(k) clearance on 2017-07-31. The listed applicant is Foosin Medical Supplies Inc., Ltd.. The 510(k) number is K170842.

When did WEGO-PTFE receive FDA 510(k) clearance?

WEGO-PTFE received FDA 510(k) clearance on 2017-07-31, under 510(k) number K170842.

Who is the listed applicant for WEGO-PTFE?

The FDA 510(k) record lists Foosin Medical Supplies Inc., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WEGO-PTFE?

The FDA product code for WEGO-PTFE is NBY.

Other records listing Foosin Medical Supplies Inc., Ltd. 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.

K201139WEGO-PDO Barbed SutureK193209Wego-Stainless SteelK183004WEGO-PGA RAPIDK183001WEGO-PGLA RAPID

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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