Cleared Traditional

easyLCTM Linear Cutter Staplers and Loading Units fot Single Use (K181657) - FDA 510(k) Clearance

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

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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 128
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