Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Foosin Medical Supplies Inc., Ltd.. It received FDA 510(k) clearance on 2017-07-31 under approval 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. It is manufactured by Foosin Medical Supplies Inc., Ltd.. The 510(k) number is K170842.

When was WEGO-PTFE approved by the FDA?

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

What company makes WEGO-PTFE?

WEGO-PTFE is manufactured by Foosin Medical Supplies Inc., Ltd..

What is the FDA product code for WEGO-PTFE?

The FDA product code for WEGO-PTFE is NBY.

Other Devices by Foosin Medical Supplies Inc., Ltd.

K183004WEGO-PGA RAPID K183001WEGO-PGLA RAPID K201139WEGO-PDO Barbed Suture K193209Wego-Stainless Steel

Related Devices (Code: NBY)

K160744LOOK PTFE SutureSurgical Specialties Corporation K163049GOLNIT Non-Absorbable PTFE Surgical SutureAntarma Dba Golnit Sutures K163639LS-5 ePTFE SutureLsi Solutions 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.

↑