Cleared Traditional

K150026 - Endopath ETS-Flex45 Endoscopic Articulating Linear Cutter, Endopath ETS-Flex45 No-Knife Articulating Linear Stapler

K150026 is an FDA 510(k) clearance for Endopath ETS-Flex45 Endoscopic Articula..., manufactured by Ethicon Endo-Surgery, LLC. The device is a Class 2 General & Plastic Surgery device with product code GDW cleared through the Traditional 510(k) pathway after a 131-day FDA review.

K150026 · Ethicon Endo-Surgery, 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
131d
Days
Class 2
Risk

K150026 is an FDA 510(k) clearance for the Endopath ETS-Flex45 Endoscopic Articulating Linear Cutter, Endopath ETS-Flex4.... Classified as Staple, Implantable (product code GDW), Class II - Special Controls.

Submitted by Ethicon Endo-Surgery, LLC (Guaynabo, PR). The FDA issued a Cleared decision on May 18, 2015 after a review of 131 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.

FDA 510(k) Submission Details - K150026

510(k) Number K150026 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 07, 2015
Decision Date May 18, 2015
Days to Decision 131 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
16d slower than avg
Panel avg: 115d · This submission: 131d
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 Consultant

Ethicon Endo-Surgery, Inc.
Christina Canter

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - GDW Staple, Implantable

All 276
Devices cleared under the same product code (GDW) and FDA review panel - the closest regulatory comparables to K150026.
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
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
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
easyEndo Linear Cutting Stapler and Loading Unit for Single Use(Stapler
K143129 · Ezisurg Medical Co., Ltd. · Jan 2015
K150026 · Endopath ETS-Flex45 Endoscopic Articulating Linear Cutter, Endopath ETS-Flex45 No-Knife Articulating Linear Stapler
Download PDF FDA Summary Ethicon Endo-Surgery,…