Cleared Traditional

K170842 - WEGO-PTFE

K170842 is an FDA 510(k) clearance for WEGO-PTFE, manufactured by Foosin Medical Supplies Inc., Ltd.. The device is a Class 2 General & Plastic Surgery device with product code NBY cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K170842 · Foosin Medical Supplies Inc., Ltd. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Jul 2017
Decision
132d
Days
Class 2
Risk

K170842 is an FDA 510(k) clearance for the WEGO-PTFE. Classified as Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene (product code NBY), Class II - Special Controls.

Submitted by Foosin Medical Supplies Inc., Ltd. (Weihai, CN). The FDA issued a Cleared decision on July 31, 2017 after a review of 132 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5035 - 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 - K170842

510(k) Number K170842 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 2017
Decision Date July 31, 2017
Days to Decision 132 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
17d slower than avg
Panel avg: 115d · This submission: 132d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NBY Device Classification - Class 2, Special Controls

Product Code NBY Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5035
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

Mid-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 - NBY Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene

All 14
Devices cleared under the same product code (NBY) and FDA review panel - the closest regulatory comparables to K170842.
PTFE SURGICAL SUTURE
K180630 · Omnia Spa · Apr 2018
C-PTFETM Surgical Suture
K173922 · Cp Medical, Inc. · Mar 2018
Gazelle PTFE and Suture Delivery Device
K173335 · Dura Tap, LLC · Feb 2018
GOLNIT Non-Absorbable PTFE Surgical Suture
K163049 · Antarma Dba Golnit Sutures · Jun 2017
LS-5 ePTFE Suture
K163639 · Lsi Solutions · Jun 2017
LOOK PTFE Suture
K160744 · Surgical Specialties Corporation · Jul 2016