Cleared Traditional

K210909 - easyEndo Lite Linear Cutting Stapler and Loading Unit for Single Use

K210909 is an FDA 510(k) clearance for easyEndo Lite Linear Cutting Stapler an..., 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 87-day FDA review.

K210909 · Ezisurg Medical Co., Ltd. · General & Plastic Surgery device
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Jun 2021
Decision
87d
Days
Class 2
Risk

K210909 is an FDA 510(k) clearance for the easyEndo Lite Linear Cutting Stapler and Loading Unit for 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 June 24, 2021 after a review of 87 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ezisurg Medical Co., Ltd. devices

FDA 510(k) Submission Details - K210909

510(k) Number K210909 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 2021
Decision Date June 24, 2021
Days to Decision 87 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
28d faster than avg
Panel avg: 115d · This submission: 87d
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-Linking 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 268
Devices cleared under the same product code (GDW) and FDA review panel - the closest regulatory comparables to K210909.
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