Cleared Special

K151163 - Signia Loading Unit, Tri-Staple 2.0 Cartridge

K151163 is an FDA 510(k) clearance for Signia Loading Unit, manufactured by Covidien, LLC. The device is a Class 2 General & Plastic Surgery device with 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) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K151163

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.

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. 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 274
Devices cleared under the same product code (GDW) and FDA review panel - the closest regulatory comparables to K151163.
PANTHER Cutter Stapler
K152618 · B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd. · Nov 2015
ReliaTack Articulating Reloadable Fixation Device with Deep Purchase Reloadable Tacks
K151659 · Covidien, LLC · Jul 2015
PANTHER Endo Linear Cutter Staplers with Single Use Loading Units
K142577 · B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd. · Jun 2015
Endopath ETS-Flex45 Endoscopic Articulating Linear Cutter, Endopath ETS-Flex45 No-Knife Articulating Linear Stapler
K150026 · Ethicon Endo-Surgery, 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
CapSure Fixation System-Straight 5mm x 37 cm-30 Permanent fasteners, CapSure Fixation System-Straight 5mm x 37 cm-15 Permanent fasteners
K142808 · C.R. Bard, Inc. · Mar 2015
K151163 · Signia Loading Unit, Tri-Staple 2.0 Cartridge
Download PDF FDA Summary Covidien, LLC