Cleared Traditional

K192637 - High Strength Suture

K192637 is an FDA 510(k) clearance for High Strength Suture, manufactured by Yunyi (Beijing) Medical Device Co., Ltd.. The device is a Class 2 General & Plastic Surgery device with product code GAT cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K192637 · Yunyi (Beijing) Medical Device Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2020
Decision
160d
Days
Class 2
Risk

K192637 is an FDA 510(k) clearance for the High Strength Suture. Classified as Suture, Nonabsorbable, Synthetic, Polyethylene (product code GAT), Class II - Special Controls.

Submitted by Yunyi (Beijing) Medical Device Co., Ltd. (Beijing, CN). The FDA issued a Cleared decision on March 2, 2020 after a review of 160 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5000 - 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 Yunyi (Beijing) Medical Device Co., Ltd. devices

FDA 510(k) Submission Details - K192637

510(k) Number K192637 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2019
Decision Date March 02, 2020
Days to Decision 160 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
45d slower than avg
Panel avg: 115d · This submission: 160d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GAT Device Classification - Class 2, Special Controls

Product Code GAT Suture, Nonabsorbable, Synthetic, Polyethylene
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5000
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 - GAT Suture, Nonabsorbable, Synthetic, Polyethylene

All 110
Devices cleared under the same product code (GAT) and FDA review panel - the closest regulatory comparables to K192637.
HS Fiber
K202242 · Riverpoint Medical, LLC · Sep 2020
Arthrex SutureTape
K193575 · Arthrex, Inc. · Jul 2020
Tevdek II, Silky II Polydek, 'Cottony' II, NextStitch
K192490 · Teleflex Medical · Mar 2020
DemeTECH DemeFORCE Nonabsorbable Surgical Suture
K190777 · Demetech Corporation · Jul 2019
Force Fiber Suture
K191268 · Teleflex Medical Incorporated · Jun 2019
HS Fiber
K190817 · Riverpoint Medical · May 2019