Cleared Traditional

K141097 - CSC SERIES INTRALUMINAL STAPLER FOR SINGLE USE (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K141097 · Touchstone International Medical Science Co., Ltd. · General & Plastic Surgery device
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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

Submission Details

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
37d slower than avg
Panel avg: 114d · This submission: 151d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 282
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