Cleared Traditional

K211811 - Disposable Endoscopic Staplers and Relo...

K211811 is an FDA 510(k) clearance for Disposable Endoscopic Staplers and Relo..., manufactured by Wuxi Beien Surgery Device 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 265-day FDA review.

K211811 · Wuxi Beien Surgery Device Co., Ltd. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Mar 2022
Decision
265d
Days
Class 2
Risk

K211811 is an FDA 510(k) clearance for the Disposable Endoscopic Staplers and Reload Unit, Disposable Hemorrhoidal Cutte.... Classified as Staple, Implantable (product code GDW), Class II - Special Controls.

Submitted by Wuxi Beien Surgery Device Co., Ltd. (Wuxi, CN). The FDA issued a Cleared decision on March 3, 2022 after a review of 265 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 Wuxi Beien Surgery Device Co., Ltd. devices

FDA 510(k) Submission Details - K211811

510(k) Number K211811 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 2021
Decision Date March 03, 2022
Days to Decision 265 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
150d slower than avg
Panel avg: 115d · This submission: 265d
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.

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All 183
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