Cleared Traditional

K160969 - ShineMed Reloadable Open Cutting Stapler

K160969 is an FDA 510(k) clearance for ShineMed Reloadable Open Cutting Stapler, manufactured by Shinemed, LLC. The device is a Class 2 General & Plastic Surgery device with product code GDW cleared through the Traditional 510(k) pathway after a 250-day FDA review.

K160969 · Shinemed, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2016
Decision
250d
Days
Class 2
Risk

K160969 is an FDA 510(k) clearance for the ShineMed Reloadable Open Cutting Stapler, ShineMed Curved Intraluminal Cuttin.... Classified as Staple, Implantable (product code GDW), Class II - Special Controls.

Submitted by Shinemed, LLC (Winter Park, US). The FDA issued a Cleared decision on December 12, 2016 after a review of 250 days - an extended review 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: 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 Shinemed, LLC devices

FDA 510(k) Submission Details - K160969

510(k) Number K160969 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 2016
Decision Date December 12, 2016
Days to Decision 250 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
135d slower than avg
Panel avg: 115d · This submission: 250d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 184
Devices cleared under the same product code (GDW) and FDA review panel - the closest regulatory comparables to K160969.
OptiFix Open Absorbable Fixation System - 20 absorbable fasteners
K163698 · C.R. Bard, Inc. · Apr 2017
Signia Four-Bay Smart Charger (to be used with Signia Stapler)
K170348 · Covidien · Mar 2017
ECHELON FLEX 45mm Powered Plus Articulating Endoscopic Linear Cutters, ECHELON ENDOPATH Endoscopic Linear Cutter Reloads, 45mm
K163454 · Ethicon Endo-Surgery, LLC · Jan 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
Signia Stapler
K160176 · Covidien · Apr 2016