Cleared Traditional

K162947 - Disposable End-to-end Anastomosis Circu...

Also marketed or referenced as:
Universal Endoscopic Linear Cutting Stapler and Single Use Loading Unit Linear Cutting Stapler and Single Use Loading Unit Disposal Hemorrhoidal Circular Stapler

K162947 is an FDA 510(k) clearance for Disposable End-to-end Anastomosis Circu..., manufactured by Chongqing Qmi Surgical 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 133-day FDA review.

K162947 · Chongqing Qmi Surgical Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2017
Decision
133d
Days
Class 2
Risk

K162947 is an FDA 510(k) clearance for the Disposable End-to-end Anastomosis Circular Stapler. Classified as Staple, Implantable (product code GDW), Class II - Special Controls.

Submitted by Chongqing Qmi Surgical Co., Ltd. (Chongqing, CN). The FDA issued a Cleared decision on March 3, 2017 after a review of 133 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 Chongqing Qmi Surgical Co., Ltd. devices

FDA 510(k) Submission Details - K162947

510(k) Number K162947 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 2016
Decision Date March 03, 2017
Days to Decision 133 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
18d slower than avg
Panel avg: 115d · This submission: 133d
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 184
Devices cleared under the same product code (GDW) and FDA review panel - the closest regulatory comparables to K162947.
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