Cleared Special

K232126 - EEACircular Stapler with Tri-Staple Tec...

K232126 is an FDA 510(k) clearance for EEACircular Stapler with Tri-Staple Tec..., manufactured by Covidien. The device is a Class 2 General & Plastic Surgery device with product code GAG cleared through the Special 510(k) pathway after a 30-day FDA review.

K232126 · Covidien · General & Plastic Surgery device
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Aug 2023
Decision
30d
Days
Class 2
Risk

K232126 is an FDA 510(k) clearance for the EEA™Circular Stapler with Tri-Staple™ Technology and OrVil™ Transoral Circula.... Classified as Stapler, Surgical (product code GAG), Class II - Special Controls.

Submitted by Covidien (Min Hang District, Shanghai, CN). The FDA issued a Cleared decision on August 16, 2023 after a review of 30 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4740 - 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.

View all Covidien devices

FDA 510(k) Submission Details - K232126

510(k) Number K232126 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 2023
Decision Date August 16, 2023
Days to Decision 30 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
85d faster than avg
Panel avg: 115d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

GAG Device Classification - Class 2, Special Controls

Product Code GAG Stapler, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4740
Definition A Surgical Stapler For Internal Use Is A Specialized Prescription Device Used To Deliver Compatible Staples To Internal Tissues During Surgery For Resection, Transection, And Creating Anastomoses.
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 - GAG Stapler, Surgical

All 32
Devices cleared under the same product code (GAG) and FDA review panel - the closest regulatory comparables to K232126.
AEON Endoscopic Powered Stapler (Short/AEPH060)
K234039 · Lexington Medical, Inc. · May 2024
GIA™ Stapler with Tri-Staple™ Technology
K231934 · Covidien · Oct 2023
TA™ Stapler and Loading Unit with DST Series™ Technology
K231491 · Covidien · Aug 2023
Tri-Staple™ 2.0 Black Circular Reloads (for use with Signia™ Circular Adapters)
K221629 · Covidien · Feb 2023
ECHELON 3000 45mm Stapler, ECHELON 3000 60mm Stapler
K213633 · Ethicon Endo-Surgery, LLC · Apr 2022
PROXIMATE DISPOSABLE SKIN STAPLER
K970079 · Ethicon Endo-Surgery, Inc. · Mar 1997