Cleared Traditional

K161757 - Single Use Curved Cutters, Single Use Circular Staplers, Single Use Linear Cutters and Reloads, Single Use Endoscopic Linear Cutters and Reloads, Single Use Hemorrhoidal Staplers, Single Use Linear Staplers and Reloads

K161757 is an FDA 510(k) clearance for Single Use Curved Cutters, manufactured by Victor Medical Instruments 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 161-day FDA review.

K161757 · Victor Medical Instruments Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2016
Decision
161d
Days
Class 2
Risk

K161757 is an FDA 510(k) clearance for the Single Use Curved Cutters, Single Use Circular Staplers, Single Use Linear Cu.... Classified as Staple, Implantable (product code GDW), Class II - Special Controls.

Submitted by Victor Medical Instruments Co., Ltd. (Changzhou, CN). The FDA issued a Cleared decision on December 5, 2016 after a review of 161 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.

FDA 510(k) Submission Details - K161757

510(k) Number K161757 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 2016
Decision Date December 05, 2016
Days to Decision 161 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
46d slower than avg
Panel avg: 115d · This submission: 161d
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 274
Devices cleared under the same product code (GDW) and FDA review panel - the closest regulatory comparables to K161757.
Single Use Circular Stapler, Single Use Hemorrhodial 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
K162710 · Tgs Medical Co., Ltd. · Feb 2017
ECHELON FLEX 45mm Powered Plus Articulating Endoscopic Linear Cutters, ECHELON ENDOPATH Endoscopic Linear Cutter Reloads, 45mm
K163454 · Ethicon Endo-Surgery, LLC · Jan 2017
ShineMed Reloadable Open Cutting Stapler, ShineMed Curved Intraluminal Cutting Stapler
K160969 · Shinemed, LLC · Dec 2016
Tri-Staple 2.0 Intelligent Cartridge
K163098 · Covidien, LLC · Dec 2016
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 · Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd · Nov 2016
FasTouch Fixation System
K162252 · Via Surgical , Ltd. · Nov 2016