Cleared Traditional

K221629 - Tri-Staple 2.0 Black Circular Reloads (...

K221629 is an FDA 510(k) clearance for Tri-Staple 2.0 Black Circular Reloads (..., manufactured by Covidien. The device is a Class 2 General & Plastic Surgery device with product code GAG cleared through the Traditional 510(k) pathway after a 261-day FDA review.

K221629 · Covidien · General & Plastic Surgery device
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Feb 2023
Decision
261d
Days
Class 2
Risk

K221629 is an FDA 510(k) clearance for the Tri-Staple™ 2.0 Black Circular Reloads (for use with Signia™ Circular Adapters). Classified as Stapler, Surgical (product code GAG), Class II - Special Controls.

Submitted by Covidien (North Haven, US). The FDA issued a Cleared decision on February 22, 2023 after a review of 261 days - an extended review 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. 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.

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FDA 510(k) Submission Details - K221629

510(k) Number K221629 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 2022
Decision Date February 22, 2023
Days to Decision 261 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
146d slower than avg
Panel avg: 115d · This submission: 261d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K221629.
GIA™ Stapler with Tri-Staple™ Technology
K231934 · Covidien · Oct 2023
TA™ Stapler and Loading Unit with DST Series™ Technology
K231491 · Covidien · Aug 2023
EEA™Circular Stapler with Tri-Staple™ Technology and OrVil™ Transoral Circular Stapler Anvil
K232126 · Covidien · Aug 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
ENDOPATH ENDOSCOPIC ARTICULATING STAPLER WITH SWEIVELING CARTRIDGE TIP
K962258 · Ethicon Endo-Surgery, Inc. · Sep 1996