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

FDA 510(k)

Wego-Stainless Steel

K-Number: K193209 · 2020-02-19

ApplicantFoosin Medical Supplies Inc., Ltd.
Decision Date2020-02-19
Product CodeGAQ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Wego-Stainless Steel 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 2020-02-19 under 510(k) number K193209. The device is classified under product code GAQ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Wego-Stainless Steel?

Wego-Stainless Steel is a medical device that received FDA 510(k) clearance on 2020-02-19. The listed applicant is Foosin Medical Supplies Inc., Ltd.. The 510(k) number is K193209.

When did Wego-Stainless Steel receive FDA 510(k) clearance?

Wego-Stainless Steel received FDA 510(k) clearance on 2020-02-19, under 510(k) number K193209.

Who is the listed applicant for Wego-Stainless Steel?

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-Stainless Steel?

The FDA product code for Wego-Stainless Steel is GAQ.

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 SutureK183004WEGO-PGA RAPIDK183001WEGO-PGLA RAPIDK170842WEGO-PTFE

Related Devices (Code: GAQ)

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.

K203855CoNextions TR Tendon Repair SystemConextions MedicalK172146MERISTEELM/s. Meril Endo Surgery Private Limited.K170767Surgical Stainless Steel Suture, Stainless Steel SutureETHICON, 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.

↑