Cleared Traditional

K160176 - Signia Stapler

K160176 is the FDA 510(k) clearance for Signia Stapler by Covidien. It is a Class 2 General & Plastic Surgery device (product code GDW) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K160176 · Covidien · General & Plastic Surgery device
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Apr 2016
Decision
90d
Days
Class 2
Risk

K160176 is an FDA 510(k) clearance for the Signia Stapler. Classified as Staple, Implantable (product code GDW), Class II - Special Controls.

Submitted by Covidien (North Haven, US). The FDA issued a Cleared decision on April 26, 2016 after a review of 90 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 devices

Submission Details

510(k) Number K160176 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 2016
Decision Date April 26, 2016
Days to Decision 90 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
25d faster than avg
Panel avg: 115d · This submission: 90d
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 135
Devices cleared under the same product code (GDW) and FDA review panel - the closest regulatory comparables to K160176.
Signia Four-Bay Smart Charger (to be used with Signia Stapler)
K170348 · Covidien · Mar 2017
Tri-Staple 2.0 Intelligent Cartridge
K163098 · Covidien, LLC · Dec 2016
CapSure Fixation System - Straight 5mm x 37 cm – 30 Permanent fasteners, CapSure Fixation System - Straight 5mm x 37 cm – 15 Permanent fasteners
K160900 · C.R. Bard, Inc. · May 2016
ReliaTack Articulating Reloadable Fixation Device with Deep Purchase Reloadable Tacks
K151659 · Covidien, LLC · Jul 2015
Signia Loading Unit, Tri-Staple 2.0 Cartridge
K151163 · Covidien, LLC · May 2015
OptiFix Fixation System - Straight 5mm X 39 cm - 30 absorbable fasteners, OptiFix Fixation System - Straight 5mm x 39 cm - 15 absorbable fasteners
K142873 · C.R. Bard, Inc. · Mar 2015