Cleared Traditional

K253657 - Tri-staple 2.0™ Reloads (FDA 510(k) Clearance)

Also includes:
Endo GIA™ Reloads with Tri-Staple™ Technology Endo GIA™ Gray Articulating Reloads Signia™ Small Diameter Reloads

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence.

K253657 · Covidien (Part of Medtronic) · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2026
Decision
141d
Days
Class 2
Risk

K253657 is an FDA 510(k) clearance for the Tri-staple 2.0™ Reloads. Classified as Staple, Implantable (product code GDW), Class II - Special Controls.

Submitted by Covidien (Part of Medtronic) (North Haven, US). The FDA issued a Cleared decision on April 10, 2026 after a review of 141 days - within the typical 510(k) review window.

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 Covidien (Part of Medtronic) devices

Submission Details

510(k) Number K253657 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 2025
Decision Date April 10, 2026
Days to Decision 141 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
27d slower than avg
Panel avg: 114d · This submission: 141d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most General & Plastic Surgery devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT05095935 Completed Observational Industry-sponsored

Medtronic Signia SDR Product Surveillance Registry

Medtronic Signia Small Diameter Reload Product Surveillance Registry

430
Patients (actual)
14
Sites
Condition studied Minimally Invasive Surgical Procedures; Surgical Procedures, Operative
Eligibility All sexes
Sponsor Medtronic (industry)
Started 2021-08-10 → Primary completion 2024-10-01
Primary outcome
Incidence of Intraoperative Hemostatic Intervention
Secondary outcome
Incidence of Repeat Hospital Admission for Primary Procedure-related Complications
View full study on ClinicalTrials.gov

Regulatory Peers - GDW Staple, Implantable

All 281
Devices cleared under the same product code (GDW) and FDA review panel - the closest regulatory comparables to K253657.
ETHICON™ 4000 45mm Compact Stapler (EC3DT45C)
K252739 · Ethicon Endo-Surgery, LLC · Dec 2025
ETHICON 4000 60mm Compact Stapler (EC3D60C)
K250835 · Ethicon Endo-Surgery, LLC · May 2025
ECHELON LINEAR™ Stapler 30mm Stapler (GTX30)
K243276 · Ethicon Endo-Surgery, LLC · Feb 2025
ECHELON 4000 60mm Compact Stapler (EC3D60C)
K241630 · Ethicon Endo-Surgery, LLC · Oct 2024
Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (30mm series)
K242679 · Fengh Medical Co., Ltd. · Oct 2024
EEA Circular Stapler with Tri-Staple Technology
K221771 · Covidien · Nov 2022