Cleared Traditional

K161905 - Disposable Circular Stapler for Hemorrhoids, Disposable Circular Stapler, Disposable Linear Stapler, Disposable Endoscopic Linear Cutter Stapler and Cartridge, Disposable Linear Cutter Stapler and Stapler Cartridge

K161905 is an FDA 510(k) clearance for Disposable Circular Stapler for Hemorrhoids, manufactured by Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd. The device is a Class 2 General & Plastic Surgery device with product code GDW cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K161905 · Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2016
Decision
129d
Days
Class 2
Risk

K161905 is an FDA 510(k) clearance for the Disposable Circular Stapler for Hemorrhoids, Disposable Circular Stapler, Dis.... Classified as Staple, Implantable (product code GDW), Class II - Special Controls.

Submitted by Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd (Changzhou, CN). The FDA issued a Cleared decision on November 17, 2016 after a review of 129 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 Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd devices

FDA 510(k) Submission Details - K161905

510(k) Number K161905 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 2016
Decision Date November 17, 2016
Days to Decision 129 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
14d slower than avg
Panel avg: 115d · This submission: 129d
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

Mid-Link Consulting Co, Ltd.
Diana Hong

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 268
Devices cleared under the same product code (GDW) and FDA review panel - the closest regulatory comparables to K161905.
ShineMed Reloadable Open Cutting Stapler, ShineMed Curved Intraluminal Cutting Stapler
K160969 · Shinemed, LLC · Dec 2016
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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