Cleared Traditional

K193209 - Wego-Stainless Steel

K193209 is an FDA 510(k) clearance for Wego-Stainless Steel, manufactured by Foosin Medical Supplies Inc., Ltd.. The device is a Class 2 General & Plastic Surgery device with product code GAQ cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K193209 · Foosin Medical Supplies Inc., Ltd. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Feb 2020
Decision
90d
Days
Class 2
Risk

K193209 is an FDA 510(k) clearance for the Wego-Stainless Steel. Classified as Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile (product code GAQ), Class II - Special Controls.

Submitted by Foosin Medical Supplies Inc., Ltd. (Weihai, CN). The FDA issued a Cleared decision on February 19, 2020 after a review of 90 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4495 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Foosin Medical Supplies Inc., Ltd. devices

FDA 510(k) Submission Details - K193209

510(k) Number K193209 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2019
Decision Date February 19, 2020
Days to Decision 90 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 115d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GAQ Device Classification - Class 2, Special Controls

Product Code GAQ Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4495
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Consultant

Med-Link Consulting Co., Ltd.
Diana Hong

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - GAQ Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile

All 18
Devices cleared under the same product code (GAQ) and FDA review panel - the closest regulatory comparables to K193209.
CoNextions TR Tendon Repair System
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MERISTEEL
K172146 · M/s. Meril Endo Surgery Private Limited. · Feb 2018
Surgical Stainless Steel Suture, Stainless Steel Suture
K170767 · Ethicon, Inc. · Nov 2017
DEMESTEEL (STAINLESS STEEL) NON-ABSORBABLE SUTURE
K141007 · Demetech Corp. · Sep 2014
FERROFIBRE STAINLESS STEEL SUTURE WITH CRIMP
K140127 · Pontis Orthopaedics, LLC · May 2014
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