Cleared Traditional

K222641 - Signia Small Diameter Reloads Including...

K222641 is the FDA 510(k) clearance for Signia Small Diameter Reloads Including... by Covidien. It is a Class 2 General & Plastic Surgery device (product code GDW) cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K222641 · Covidien · General & Plastic Surgery device
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Nov 2022
Decision
89d
Days
Class 2
Risk

K222641 is an FDA 510(k) clearance for the Signia™ Small Diameter Reloads Including Regular (Round) Tip Version. Classified as Staple, Implantable (product code GDW), Class II - Special Controls.

Submitted by Covidien (North Haven, US). The FDA issued a Cleared decision on November 29, 2022 after a review of 89 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Covidien devices

Submission Details

510(k) Number K222641 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 2022
Decision Date November 29, 2022
Days to Decision 89 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 faster than avg
Panel avg: 115d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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. 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 157
Devices cleared under the same product code (GDW) and FDA review panel - the closest regulatory comparables to K222641.
ECHELON LINEAR™ 60 mm Cutter (GLC60)
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EEA Circular Stapler with Tri-Staple Technology
K221771 · 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
EEA Circular Stapler with Tri-Staple Technology
K221005 · Covidien · Apr 2022