Cleared Traditional

K130738 - ENDOSCOPIC LINEAR CUTTING STAPLERS WITH SINGLE USE LOADING UNITS

K130738 is an FDA 510(k) clearance for ENDOSCOPIC LINEAR CUTTING STAPLERS WITH..., manufactured by Nanjing Maidixin Medical Device 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 270-day FDA review.

K130738 · Nanjing Maidixin Medical Device Co., Ltd. · General & Plastic Surgery device
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Dec 2013
Decision
270d
Days
Class 2
Risk

K130738 is an FDA 510(k) clearance for the ENDOSCOPIC LINEAR CUTTING STAPLERS WITH SINGLE USE LOADING UNITS. Classified as Staple, Implantable (product code GDW), Class II - Special Controls.

Submitted by Nanjing Maidixin Medical Device Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on December 13, 2013 after a review of 270 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.

View all Nanjing Maidixin Medical Device Co., Ltd. devices

FDA 510(k) Submission Details - K130738

510(k) Number K130738 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 2013
Decision Date December 13, 2013
Days to Decision 270 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
155d slower than avg
Panel avg: 115d · This submission: 270d
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 K130738.
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K133762 · Covidien, LLC · Jan 2014
OPTIFIX ABSORBABLE FIXATION SYSTEM
K132134 · C.R. Bard, Inc. · Dec 2013
ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY
K132493 · Covidien, LLC · Oct 2013
ECHELON ENDOSCOPIC LINEAR CUTTER RELOAD, BLACK
K131663 · Ethicon Endo-Surgery, LLC · Oct 2013