Cleared Traditional

K253657 - Tri-staple 2.0™ Reloads

Also marketed or referenced as:
Endo GIA™ Reloads with Tri-Staple™ Technology Endo GIA™ Gray Articulating Reloads Signia™ Small Diameter Reloads

K253657 is an FDA 510(k) clearance for Tri-staple 2.0 Reloads, manufactured by Covidien (Part of Medtronic). The device is a Class 2 General & Plastic Surgery device with product code GDW cleared through the Traditional 510(k) pathway after a 141-day FDA review.

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

FDA 510(k) Submission Details - K253657

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
26d slower than avg
Panel avg: 115d · This submission: 141d
Pathway characteristics
Predicate-based equivalence.

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. 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 240
Devices cleared under the same product code (GDW) and FDA review panel - the closest regulatory comparables to K253657.
ETHICON™ Circular Stapler (CDH21mm)
K260196 · Ethicon Endo-Surgery, LLC · May 2026
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