Cleared Traditional

K211458 - Disposable Anorectal Staplers

K211458 is an FDA 510(k) clearance for Disposable Anorectal Staplers, manufactured by Ningbo Verykind Medical 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 233-day FDA review.

K211458 · Ningbo Verykind Medical Device Co., Ltd. · General & Plastic Surgery device
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Dec 2021
Decision
233d
Days
Class 2
Risk

K211458 is an FDA 510(k) clearance for the Disposable Anorectal Staplers, Disposable Intraluminal Staplers, Disposable L.... Classified as Staple, Implantable (product code GDW), Class II - Special Controls.

Submitted by Ningbo Verykind Medical Device Co., Ltd. (Ningbo, CN). The FDA issued a Cleared decision on December 30, 2021 after a review of 233 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 Ningbo Verykind Medical Device Co., Ltd. devices

FDA 510(k) Submission Details - K211458

510(k) Number K211458 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 2021
Decision Date December 30, 2021
Days to Decision 233 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
118d slower than avg
Panel avg: 115d · This submission: 233d
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 161
Devices cleared under the same product code (GDW) and FDA review panel - the closest regulatory comparables to K211458.
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