Cleared Traditional

K161905 - Disposable Circular Stapler for Hemorrhoids

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
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 Peers - GDW Staple, Implantable

All 162
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