Cleared Traditional

K182217 - Linear Cutter Staplers and Loading Units for Single Use, Circular Staplers for Single Use (FDA 510(k) Clearance)

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

K182217 · Ezisurg (Suzhou) Medical Co., Ltd. · General & Plastic Surgery device
Apr 2019
Decision
244d
Days
Class 2
Risk

K182217 is an FDA 510(k) clearance for the Linear Cutter Staplers and Loading Units for Single Use, Circular Staplers fo.... Classified as Staple, Implantable (product code GDW), Class II - Special Controls.

Submitted by Ezisurg (Suzhou) Medical Co., Ltd. (Suzhou, CN). The FDA issued a Cleared decision on April 16, 2019 after a review of 244 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.

Submission Details

510(k) Number K182217 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 2018
Decision Date April 16, 2019
Days to Decision 244 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
112d slower than avg
Panel avg: 132d · This submission: 244d
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 Peers - GDW Staple, Implantable

All 11
Devices cleared under the same product code (GDW) and FDA review panel - the closest regulatory comparables to K182217.
ETHICON™ 4000 45mm Compact Stapler (EC3DT45C)
K252739 · Ethicon Endo-Surgery, LLC · Dec 2025
ETHICON 4000 60mm Compact Stapler (EC3D60C)
K250835 · Ethicon Endo-Surgery, LLC · May 2025
ECHELON LINEAR™ Stapler 30mm Stapler (GTX30)
K243276 · Ethicon Endo-Surgery, LLC · Feb 2025
ECHELON 4000 60mm Compact Stapler (EC3D60C)
K241630 · Ethicon Endo-Surgery, LLC · Oct 2024
EEA Circular Stapler with Tri-Staple Technology
K221771 · Covidien · Nov 2022
Signia™ Small Diameter Reloads Including Regular (Round) Tip Version
K222641 · Covidien · Nov 2022