Cleared Special

K172538 - Disposable Linear Stapler, Disposable Linear Cutter

K172538 is an FDA 510(k) clearance for Disposable Linear Stapler, manufactured by Changzhou Kangdi Medical Stapler Co., Ltd.. The device is a Class 2 General & Plastic Surgery device with product code GDW cleared through the Special 510(k) pathway after a 100-day FDA review.

K172538 · Changzhou Kangdi Medical Stapler Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2017
Decision
100d
Days
Class 2
Risk

K172538 is an FDA 510(k) clearance for the Disposable Linear Stapler, Disposable Linear Cutter. Classified as Staple, Implantable (product code GDW), Class II - Special Controls.

Submitted by Changzhou Kangdi Medical Stapler Co., Ltd. (Changzhou City, CN). The FDA issued a Cleared decision on November 30, 2017 after a review of 100 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. 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Changzhou Kangdi Medical Stapler Co., Ltd. devices

FDA 510(k) Submission Details - K172538

510(k) Number K172538 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 2017
Decision Date November 30, 2017
Days to Decision 100 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
15d faster than avg
Panel avg: 115d · This submission: 100d
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 Consultant

Irc
Charlie Mack

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 273
Devices cleared under the same product code (GDW) and FDA review panel - the closest regulatory comparables to K172538.
AEON Endoscopic Stapler
K173443 · Lexington Medical, Inc. · Feb 2018
easyEndoTM Linear Cutting Stapler and Loading Units for Single Use, easyEndoTM Universal Linear Cutting Stapler and Loading Units for Single Use
K172960 · Ezisurg Medical Co., Ltd. · Dec 2017
Disposable Circular Stapler
K172561 · Changzhou Kangdi Medical Stapler Co., Ltd. · Dec 2017
AEON Endoscopic Stapler
K171589 · Lexington Medical, Inc. · Nov 2017
Dextera MicroCutter 30 Blue Reload, Dextera MicroCutter 30 Curved Tip Blue Reload, Dextera MicroCutter 30 White Reload, Dextera MicroCutter 30 Curved Tip White Reload
K171561 · Dextera Surgical, Inc. · Aug 2017
Single Use Circular Stapler, Single Use Hemorrhoidal Circular Stapler, Single Patient Use Linear Stapler and Reload, Single Patient Use Linear Cutter and Reload, Single Patient Use Endo Cutter and Reload, Single Patient Use Transverse Cutter and Reload
K162707 · Golden Stapler Surgical Co., Ltd. · Jul 2017