Cleared Special

K151163 - Signia Loading Unit

K151163 is the FDA 510(k) clearance for Signia Loading Unit by Covidien, LLC. It is a Class 2 General & Plastic Surgery device (product code GDW) cleared through the Special 510(k) pathway after a 28-day FDA review.

K151163 · Covidien, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2015
Decision
28d
Days
Class 2
Risk

K151163 is an FDA 510(k) clearance for the Signia Loading Unit, Tri-Staple 2.0 Cartridge. Classified as Staple, Implantable (product code GDW), Class II - Special Controls.

Submitted by Covidien, LLC (North Haven, US). The FDA issued a Cleared decision on May 29, 2015 after a review of 28 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. 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, LLC devices

Submission Details

510(k) Number K151163 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2015
Decision Date May 29, 2015
Days to Decision 28 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
87d faster than avg
Panel avg: 115d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 135
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