Cleared Traditional

K181657 - easyLCTM Linear Cutter Staplers and Loa...

Also marketed or referenced as:
easyCSTM Circular Stapler for Single Use

K181657 is an FDA 510(k) clearance for easyLCTM Linear Cutter Staplers and Loa..., manufactured by Ezisurg Medical Co., Ltd.. The device is a Class 2 General & Plastic Surgery device with product code GDW cleared through the Traditional 510(k) pathway after a 224-day FDA review.

K181657 · Ezisurg Medical Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2019
Decision
224d
Days
Class 2
Risk

K181657 is an FDA 510(k) clearance for the easyLCTM Linear Cutter Staplers and Loading Units fot Single Use. Classified as Staple, Implantable (product code GDW), Class II - Special Controls.

Submitted by Ezisurg Medical Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on February 1, 2019 after a review of 224 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4750 - 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 Ezisurg Medical Co., Ltd. devices

FDA 510(k) Submission Details - K181657

510(k) Number K181657 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 2018
Decision Date February 01, 2019
Days to Decision 224 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
109d slower than avg
Panel avg: 115d · This submission: 224d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GDW Device Classification - Class 2, Special Controls

Product Code GDW Staple, Implantable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4750
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 - GDW Staple, Implantable

All 183
Devices cleared under the same product code (GDW) and FDA review panel - the closest regulatory comparables to K181657.
FasTouch Absorbable Fixation System
K181668 · Via Surgical , Ltd. · Mar 2019
easyPPHTM Hemorrhoidal Stapler for Single Use
K183477 · Ezisurg Medical Co., Ltd. · Feb 2019
Echelon Endoscopic Linear Cutter Reloads, White, Blue, Gold, Green and Black
K183435 · Ethicon Endo-Surgery, LLC · Feb 2019
SignalMark Lung Biopsy Site Marker
K180175 · View Point Medical, Inc. · Dec 2018
AEON Endoscopic Stapler
K182380 · Lexington Medical, Inc. · Nov 2018
Endoscopic Linear Cutting Staplers and Loading Units for Single Use
K181620 · Ezisurg (Suzhou) Medical Co., Ltd. · Sep 2018