Cleared Special

K221005 - EEA Circular Stapler with Tri-Staple Technology

K221005 is an FDA 510(k) clearance for EEA Circular Stapler with Tri-Staple Te..., manufactured by Covidien. The device is a Class 2 General & Plastic Surgery device with product code GDW cleared through the Special 510(k) pathway after a 24-day FDA review.

K221005 · Covidien · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2022
Decision
24d
Days
Class 2
Risk

K221005 is an FDA 510(k) clearance for the EEA Circular Stapler with Tri-Staple Technology. Classified as Staple, Implantable (product code GDW), Class II - Special Controls.

Submitted by Covidien (Shanghai, CN). The FDA issued a Cleared decision on April 29, 2022 after a review of 24 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K221005

510(k) Number K221005 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 2022
Decision Date April 29, 2022
Days to Decision 24 days
Submission Type Special
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
91d faster than avg
Panel avg: 115d · This submission: 24d
Pathway characteristics
Modification to existing cleared device.

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 Peers - GDW Staple, Implantable

All 284
Devices cleared under the same product code (GDW) and FDA review panel - the closest regulatory comparables to K221005.
Signia™ Small Diameter Reloads Including Regular (Round) Tip Version
K222641 · Covidien · Nov 2022
Autosuture EEA Stapler / circular stapler with DST Series Technology / EEA Autosuture Circular Stapler with DST Series Technology / DST Series EEA Stapler / DST EEA
K221003 · Covidien · Sep 2022
GIA Auto Suture Stapler with DST Series Technology
K221013 · Covidien · May 2022
GIA Stapler with Tri-Staple Technology
K221006 · Covidien · Apr 2022
Disposable Endoscopic Staplers and Reload Unit, Disposable Hemorrhoidal Cutter Staplers, Disposable Linear Cutter Staplers, Disposable Circular Staplers
K211811 · Wuxi Beien Surgery Device Co., Ltd. · Mar 2022
Disposable Anorectal Staplers, Disposable Intraluminal Staplers, Disposable Linear Cutting Staplers, Disposable Endoscopic Cutting Staplers
K211458 · Ningbo Verykind Medical Device Co., Ltd. · Dec 2021
K221005 · EEA Circular Stapler with Tri-Staple Technology
Download PDF FDA Summary Covidien