Cleared Traditional

K141097 - CSC SERIES INTRALUMINAL STAPLER FOR SIN...

K141097 is an FDA 510(k) clearance for CSC SERIES INTRALUMINAL STAPLER FOR SIN..., manufactured by Touchstone International Medical Science 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 151-day FDA review.

K141097 · Touchstone International Medical Science Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2014
Decision
151d
Days
Class 2
Risk

K141097 is an FDA 510(k) clearance for the CSC SERIES INTRALUMINAL STAPLER FOR SINGLE USE. Classified as Staple, Implantable (product code GDW), Class II - Special Controls.

Submitted by Touchstone International Medical Science Co., Ltd. (Suzhou, Jiangsu, CN). The FDA issued a Cleared decision on September 26, 2014 after a review of 151 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 Touchstone International Medical Science Co., Ltd. devices

FDA 510(k) Submission Details - K141097

510(k) Number K141097 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 2014
Decision Date September 26, 2014
Days to Decision 151 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
36d slower than avg
Panel avg: 115d · This submission: 151d
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
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